Trial Outcomes & Findings for Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer (NCT NCT00057876)
NCT ID: NCT00057876
Last Updated: 2023-07-05
Results Overview
Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
74 participants
Primary outcome timeframe
assessed every 3 months for 2 years, then every 6 months for year 3
Results posted on
2023-07-05
Participant Flow
The study was activated on April 10,2003, accrued its first patient on August 29, 2003, and terminated on December 15, 2005 as a result of slow accrual. The final accrual of the study was 74 patients. This was an intergroup study and coordinated by Eastern Cooperative Oncology Group with 9 participating groups.
Participant milestones
| Measure |
Gemcitabine
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
36
|
|
Overall Study
Eligible
|
37
|
34
|
|
Overall Study
Began Protocol Therapy
|
35
|
34
|
|
Overall Study
Eligible and Treated
|
34
|
34
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
29
|
27
|
Reasons for withdrawal
| Measure |
Gemcitabine
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
8
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Lack of Efficacy
|
10
|
8
|
|
Overall Study
Ineligible
|
1
|
2
|
|
Overall Study
other reason
|
2
|
2
|
|
Overall Study
other complicating disease
|
1
|
0
|
Baseline Characteristics
Gemcitabine With or Without Radiation Therapy in Treating Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine
n=37 Participants
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=34 Participants
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
65.3 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
66.2 years
STANDARD_DEVIATION 9.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=99 Participants
|
34 participants
n=107 Participants
|
71 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: assessed every 3 months for 2 years, then every 6 months for year 3Population: 71 eligible patients
Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.
Outcome measures
| Measure |
Gemcitabine
n=37 Participants
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=34 Participants
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Overall Survival Time
|
9.2 Months
Interval 7.9 to 11.4
|
11.0 Months
Interval 7.6 to 15.5
|
SECONDARY outcome
Timeframe: assessed every 3 months for 2 years, then every 6 months for year 3Population: 67 eligible patients with data on progression-free survival(PFS)
Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.
Outcome measures
| Measure |
Gemcitabine
n=34 Participants
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=33 Participants
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Progression-free Survival Time
|
6.7 Months
Interval 3.9 to 8.7
|
6.0 Months
Interval 5.4 to 8.4
|
SECONDARY outcome
Timeframe: assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3Population: Eligible patients
Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.
Outcome measures
| Measure |
Gemcitabine
n=37 Participants
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=34 Participants
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Overall Response
|
2 participants
|
2 participants
|
Adverse Events
Gemcitabine
Serious events: 28 serious events
Other events: 5 other events
Deaths: 0 deaths
Gemcitabine + Radiation
Serious events: 28 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine
n=35 participants at risk
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=34 participants at risk
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
17.6%
6/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Leukopenia
|
14.3%
5/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
32.4%
11/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Neutrophenia
|
40.0%
14/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
41.2%
14/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Lymphopenia
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Thrombocytopenia
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
20.6%
7/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Transfusion: platelets
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Blood and lymphatic system disorders
Transfusion:PRBCS
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
17.6%
6/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Cardiac disorders
Cardiac-Ischemia
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
General disorders
Edema
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Vascular disorders
Hypertension
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Vascular disorders
Thrombosis/Embolism
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
General disorders
Fatigue
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
32.4%
11/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Weight loss
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
17.6%
6/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Colitis
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
29.4%
10/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
26.5%
9/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea W/O prior colostomy
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Bilirubin increased
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Investigations
Gamma-glutamyl transpeptidase (GGT) increase
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
8.8%
3/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Hepatobiliary disorders
AST increased
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Hepatobiliary disorders
ALT increased
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Infections and infestations
Infection W/grade 3 or 4 neutropenia
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Infections and infestations
Infection with unknown ANC
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Abonominal pain
|
0.00%
0/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Plumonary-other
|
2.9%
1/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
0.00%
0/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
Other adverse events
| Measure |
Gemcitabine
n=35 participants at risk
Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.
Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
|
Gemcitabine + Radiation
n=34 participants at risk
Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.
Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.4%
4/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
General disorders
Weight loss
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
5.9%
2/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
2.9%
1/34 • Assessed at the end of the rest period following induction, and again 4 weeks after the end of consolidation and for 30 days after the end of treatment
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group (ECOG) Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place