Trial Outcomes & Findings for Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer (NCT NCT00608205)
NCT ID: NCT00608205
Last Updated: 2020-08-06
Results Overview
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
COMPLETED
PHASE3
69 participants
at 2 yrs from start of study
2020-08-06
Participant Flow
Patients recruited from Cleveland, Ohio medical clinics from December 2007 to August 2012.
Participant milestones
| Measure |
Arm A: Radiation With Concurrent Cisplatin
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B: Radiation With Concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
34
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Arm A: Radiation With Concurrent Cisplatin
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B: Radiation With Concurrent 5-FU and Cisplatin
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Patient non-compliant
|
0
|
1
|
Baseline Characteristics
Radiation Therapy Cisplatin With or Without Fluorouracil Patients With Stage III or Stage IV Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Radiation With Concurrent Cisplatin
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B: Radiation With Concurrent 5-FU and Cisplatin
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
6 participants
n=39 Participants
|
10 participants
n=41 Participants
|
16 participants
n=35 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=39 Participants
|
16 participants
n=41 Participants
|
27 participants
n=35 Participants
|
|
Age, Customized
60-69 years
|
17 participants
n=39 Participants
|
6 participants
n=41 Participants
|
23 participants
n=35 Participants
|
|
Age, Customized
70-79 years
|
1 participants
n=39 Participants
|
2 participants
n=41 Participants
|
3 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
60 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=39 Participants
|
34 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=39 Participants
|
34 participants
n=41 Participants
|
69 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: at 2 yrs from start of studyPopulation: intention to treat (ITT)
Number of patients that are alive without recurrence when recurrence is defined by any subject with new evidence of cancer after achieving a complete response. Complete response is defined by the complete disappearance of all clinically and radiologically detectable tumor..
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Relapse Free Survival
|
30 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 2 years from start of studyPopulation: intention to treat (ITT)
Patients with any new evidence of cancer after achieving a complete response are considered to have recurrent disease. Biopsy verification will be obtained if at all possible and salvage surgery is recommended if possible. Disease recurrence will be characterized as either local, regional(nodal) or distant recurrence. Patients may have more than one kind of recurrence.
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Patterns of Failure
Local recurrence
|
1 participants
|
1 participants
|
|
Patterns of Failure
Regional (nodal) recurrence
|
1 participants
|
0 participants
|
|
Patterns of Failure
Distant recurrence
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 2 yrs from start of studyPopulation: intention to treat (ITT)
Number of patients still alive from 2 years from start of study
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Overall Survival
|
34 participants
|
29 participants
|
SECONDARY outcome
Timeframe: at 12 weeks after completing chemoradiotherapyPopulation: intention to treat (ITT)
Twelve weeks after completing chemoradiotherapy, a formal evaluation for response will be made, to include a careful evaluation by the head and neck surgeon, medical and radiation oncologists, and, as appropriate, a radiologic and an endoscopic examination. Patients will be considered to have achieved either a clinical complete response (i.e. complete disappearance of all clinically and radiologically detectable tumor) or to have clinical persistent disease.
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients With a Clinical Response-complete Disappearance of Detectable Tumor
|
35 participants
|
28 participants
|
SECONDARY outcome
Timeframe: at 12 weeks after completing chemoradiotherapy and surgeryA Pathological, or final response will be assigned to subjects after any salvage surgery is performed for clinical persistent disease, and after planned neck dissection in those achieving a clinical complete response. If no surgery is performed after chemoradiotherapy, the clinical and pathological (final) response will be the same. Patient will be coded as having either a pathologic complete response, or as having pathologic persistent disease. A pathologic complete response will be defined as the total disappearance of all clinically and radiologically detectable tumor.
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=34 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients With a Pathological(Final)Complete Response
|
35 participants
|
31 participants
|
SECONDARY outcome
Timeframe: 2 years after start of studyPopulation: Patients that had a complete response after 12 weeks of therapy
Number of patients with any new evidence of cancer after achieving a complete response (at 12 weeks after completing chemoradiotherapy) are considered to have recurrent disease.
Outcome measures
| Measure |
Arm A
n=35 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=31 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Disease Recurrence
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Outcome measures
| Measure |
Arm A
n=29 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients That Required a Feeding Tube
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 8 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=24 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients That Required a Feeding Tube
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients That Required a Feeding Tube
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Outcome measures
| Measure |
Arm A
n=21 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=17 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Number of Patients That Required a Feeding Tube
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). N (number of patients analyzed) is based on number of patients who completed the question.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Nausea Level
|
0.07 units on a scale
Standard Deviation 0.26
|
0.12 units on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: 8 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Nausea Level
|
0.15 units on a scale
Standard Deviation 0.46
|
0.09 units on a scale
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: 12 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have nausea". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Nausea Level
|
0.14 units on a scale
Standard Deviation 0.45
|
0.04 units on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 24 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have nausea".
Outcome measures
| Measure |
Arm A
n=21 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Nausea Level
|
0.10 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "My mouth is dry". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=25 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Dry Mouth
|
3.33 units on a scale
Standard Deviation 0.83
|
3.08 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 8 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "My mouth is dry". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Dry Mouth
|
2.67 units on a scale
Standard Deviation 1.07
|
3.09 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 12 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "My mouth is dry". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=22 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Dry Mouth
|
2.70 units on a scale
Standard Deviation 1.03
|
3.09 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 24 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "My mouth is dry". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=20 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Dry Mouth
|
2.60 units on a scale
Standard Deviation 1.10
|
2.94 units on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=29 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Pain
|
1.24 units on a scale
Standard Deviation 1.06
|
1.42 units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 8 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=26 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Pain
|
0.65 units on a scale
Standard Deviation 0.80
|
0.74 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 12 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Pain
|
0.57 units on a scale
Standard Deviation 0.74
|
0.57 units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: 24 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I have pain in my mouth, throat or neck". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=20 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Pain
|
0.60 units on a scale
Standard Deviation 0.75
|
0.75 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am content with the quality of my life right now". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=25 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Quality of Life
|
1.37 units on a scale
Standard Deviation 1.08
|
1.68 units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 8 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am content with the quality of my life right now". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Quality of Life
|
0.85 units on a scale
Standard Deviation 1.13
|
1.13 units on a scale
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 12 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am content with the quality of my life right now". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=22 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Quality of Life
|
0.67 units on a scale
Standard Deviation 1.00
|
0.95 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: 24 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am content with the quality of my life right now". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=21 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Quality of Life
|
0.62 units on a scale
Standard Deviation 0.86
|
0.88 units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am able to eat the foods i like". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=25 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Eating
|
2.33 units on a scale
Standard Deviation 1.07
|
2.28 units on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 8 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am able to eat the foods i like". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Eating
|
1.93 units on a scale
Standard Deviation 1.17
|
1.78 units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 12 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am able to eat the foods i like". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=21 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Eating
|
1.56 units on a scale
Standard Deviation 1.25
|
1.24 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 24 months from start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I am able to eat the foods i like". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=21 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Eating
|
1.52 units on a scale
Standard Deviation 1.17
|
1.13 units on a scale
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can swallow naturally and easily". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=29 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Swallowing
|
1.93 units on a scale
Standard Deviation 1.07
|
2.31 units on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 8 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can swallow naturally and easily". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=26 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Swallowing
|
1.31 units on a scale
Standard Deviation 1.12
|
1.83 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 12 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can swallow naturally and easily". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=28 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Swallowing
|
1.61 units on a scale
Standard Deviation 1.13
|
1.52 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 24 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can swallow naturally and easily". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=20 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Swallowing
|
1.45 units on a scale
Standard Deviation 1.00
|
1.63 units on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=29 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Alcohol Consumption
|
3.28 units on a scale
Standard Deviation 0.65
|
3.27 units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 8 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=25 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Alcohol Consumption
|
2.96 units on a scale
Standard Deviation 0.89
|
3.00 units on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: 12 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Alcohol Consumption
|
2.85 units on a scale
Standard Deviation 0.72
|
2.91 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: 24 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I drink alcohol (e.g. beer, wine)". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=20 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Alcohol Consumption
|
2.85 units on a scale
Standard Deviation 0.88
|
2.81 units on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: 12 weeks (after treatment)Population: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can eat solid foods". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=29 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=26 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Solid Foods
|
1.41 units on a scale
Standard Deviation 1.35
|
1.73 units on a scale
Standard Deviation 1.15
|
SECONDARY outcome
Timeframe: 8 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can eat solid foods". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=26 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Solid Foods
|
0.96 units on a scale
Standard Deviation 1.15
|
1.13 units on a scale
Standard Deviation 1.06
|
SECONDARY outcome
Timeframe: 12 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can eat solid foods". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=27 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=23 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Solid Foods
|
0.78 units on a scale
Standard Deviation 0.97
|
0.70 units on a scale
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 24 months after start of treatmentPopulation: Patients still alive from Cleveland Clinic only. University Hospital patients were not included in this analysis.
Quality of life questionnaire asking "I can eat solid foods". The Categories were assigned a number. The categories were: Not at all (0), A little bit (1), Somewhat (2), Quite a bit (3), Very much (4). The mean was determined from each statement.
Outcome measures
| Measure |
Arm A
n=20 Participants
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B
n=16 Participants
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Solid Foods
|
0.85 units on a scale
Standard Deviation 0.93
|
0.56 units on a scale
Standard Deviation 0.89
|
Adverse Events
Arm A: Radiation With Concurrent Cisplatin
Arm B: Radiation With Concurrent 5-FU and Cisplatin
Serious adverse events
| Measure |
Arm A: Radiation With Concurrent Cisplatin
n=35 participants at risk
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B: Radiation With Concurrent 5-FU and Cisplatin
n=34 participants at risk
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Adverse event data was collected over a 2 year period from study start.
|
8.8%
3/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
0.00%
0/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Cardiac disorders
Cardiac
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
5.9%
2/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Nervous system disorders
Cranial Neuropathy/ Hearing and Balance
|
8.6%
3/35 • Adverse event data was collected over a 2 year period from study start.
|
0.00%
0/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Blood and lymphatic system disorders
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
5.7%
2/35 • Adverse event data was collected over a 2 year period from study start.
|
26.5%
9/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Investigations
Hypokalemia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Malnutrition
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
5.9%
2/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Mucositis/Dysphagia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
8.8%
3/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
0.00%
0/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
General disorders
Pain-not otherwise specified (NOS)
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
0.00%
0/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
5.9%
2/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Renal and urinary disorders
Renal Insufficiency
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
0.00%
0/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Vascular disorders
Thrombosis/embolism
|
5.7%
2/35 • Adverse event data was collected over a 2 year period from study start.
|
8.8%
3/34 • Adverse event data was collected over a 2 year period from study start.
|
Other adverse events
| Measure |
Arm A: Radiation With Concurrent Cisplatin
n=35 participants at risk
Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
|
Arm B: Radiation With Concurrent 5-FU and Cisplatin
n=34 participants at risk
Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
|
|---|---|---|
|
Nervous system disorders
Cranial Neuropathy/ Hearing and Balance
|
2.9%
1/35 • Adverse event data was collected over a 2 year period from study start.
|
0.00%
0/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
94.3%
33/35 • Adverse event data was collected over a 2 year period from study start.
|
100.0%
34/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Endocrine disorders
Hypothyroidism
|
40.0%
14/35 • Adverse event data was collected over a 2 year period from study start.
|
47.1%
16/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Investigations
Increased Creatinine
|
25.7%
9/35 • Adverse event data was collected over a 2 year period from study start.
|
2.9%
1/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Mucositis
|
97.1%
34/35 • Adverse event data was collected over a 2 year period from study start.
|
97.1%
33/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Mucositis/Dysphagia
|
97.1%
34/35 • Adverse event data was collected over a 2 year period from study start.
|
100.0%
34/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
77.1%
27/35 • Adverse event data was collected over a 2 year period from study start.
|
67.6%
23/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.3%
12/35 • Adverse event data was collected over a 2 year period from study start.
|
61.8%
21/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Injury, poisoning and procedural complications
Skin Toxicity from Radiation
|
94.3%
33/35 • Adverse event data was collected over a 2 year period from study start.
|
88.2%
30/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Gastrointestinal disorders
Stomatitis
|
37.1%
13/35 • Adverse event data was collected over a 2 year period from study start.
|
52.9%
18/34 • Adverse event data was collected over a 2 year period from study start.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
10/35 • Adverse event data was collected over a 2 year period from study start.
|
41.2%
14/34 • Adverse event data was collected over a 2 year period from study start.
|
Additional Information
Dr. David Adelstein
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place