Trial Outcomes & Findings for Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy (NCT NCT00765570)
NCT ID: NCT00765570
Last Updated: 2015-05-18
Results Overview
Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.
Results posted on
2015-05-18
Participant Flow
Subjects were screened and enrolled from the physicians offices at Summa Health System.
Participant milestones
| Measure |
Treatment Group 1
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
|
Treatment Group-2
Treatment Group 2:15 treatments with standard radiation
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Advanced Bulky Malignancies With Spatially Fractioned Radiation Therapy
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=9 Participants
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
|
Treatment Group-2
n=3 Participants
Treatment Group 2: 15 treatments with standard radiation
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 12 • n=99 Participants
|
69 years
STANDARD_DEVIATION 9 • n=107 Participants
|
72 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.Number of grade 3 or higher complications during the assesment period. This does not include any complication felt to be due solely to malignancy
Outcome measures
| Measure |
Treatment Group 1
n=9 Participants
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
|
Treatment Group-2
n=3 Participants
Treatment Group 2: 15 treatments with standard radiation
|
|---|---|---|
|
Protocol Treatment Related Morbidity
Grade 3 Adverse Events
|
0 events
|
0 events
|
|
Protocol Treatment Related Morbidity
Grade 4 Adverse Events
|
0 events
|
0 events
|
|
Protocol Treatment Related Morbidity
Grade 5 Adverse Events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: during duration of treatment of 3 weeks. Follow up exams every 6 months for the next two years and then yearly for the rest of your life.Complete response (CR) = 100% tumor disappearance Partial response (PR) = \> 50% reduction in size Stable disease (SD) = \< 50% reduction or no change +/- 10% increase in tumor size Progressive disease (PD) = \> 10% increase in size of tumor Unknown Status (UK)
Outcome measures
| Measure |
Treatment Group 1
n=9 Participants
Treatment Group 1: one treatment of Grid therapy followed by 15 treatments with standard radiation
|
Treatment Group-2
n=3 Participants
Treatment Group 2: 15 treatments with standard radiation
|
|---|---|---|
|
Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.
Complete Response (CR)
|
1 participants
|
0 participants
|
|
Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.
Partial response (PR)
|
0 participants
|
1 participants
|
|
Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.
Stable disease (SD)
|
6 participants
|
2 participants
|
|
Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.
Progressive disease (PD)
|
1 participants
|
0 participants
|
|
Objective Response of Bulky Tumors of the Head and Neck Area, Lung, Abdomen or Pelvis to Standard Fractionated Radiation Therapy Plus Grid Therapy Compared to Standard Fractionated Radiation Therapy Alone.
Unknown (UK)
|
1 participants
|
0 participants
|
Adverse Events
Treatment Group 1
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment Group-2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group 1
n=9 participants at risk
Treatment Group 1-one treatment of Grid therapy followed by 15 treatments with standard radiation
|
Treatment Group-2
n=3 participants at risk
Treatment Group 2-15 treatments with standard radiation
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Toxicity
|
66.7%
6/9 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
66.7%
2/3 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Toxicity
|
44.4%
4/9 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
33.3%
1/3 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
|
Nervous system disorders
CNS Toxicity
|
11.1%
1/9 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
0.00%
0/3 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
|
Gastrointestinal disorders
GI or GU Toxicity
|
33.3%
3/9 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
0.00%
0/3 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
|
General disorders
other
|
33.3%
3/9 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
33.3%
1/3 • Patients were to be assessed at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 6 months, 9 months and 1 year after treatment was completed. Follow-up after 1 year was to be at 6 month intervals until 2 years, then annually.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place