A Phase 3 interventional study of Gemcitabine and radiation therapy in Pancreatic Cancer, sponsored by Eastern Cooperative Oncology Group. Completed at 229 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Eastern Cooperative Oncology Group · Phase 3, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs. 1) and weight loss within the past 6 months (less than 10% vs. 10% or more). Patients are randomized to 1 of 2 treatment arms.
Arm I (Gemcitabine alone):
Arm II (Gemcitabine with radiotherapy):
Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival.
ACCRUAL: 74 patients were accrued for this study.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 74 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Adequate bone marrow reserve,liver and renal function within 2 weeks of randomization:
Exclusion Criteria:
Drug: Gemcitabine
Radiation: radiation therapy
Induction: Patients receive the first cycle of gemcitabine 1000 mg/m\^2 intravenously once per week for 6 weeks followed by 1 week rest. Consolidation: Following the week of rest, treatment resume with gemcitabine 1000 mg/m\^2 administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles.
Also known as: 2-Deoxy-2, 2-difluorocytidine monohydrochloride, Gemzar
Induction: Patients receive gemcitabine 600 mg/m\^2 intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose is given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction is 180 cGy prescribed to the isocenter. The total dose of radiation is 5040 cGy given in 28 fractions over 5 1/2 weeks. Consolidation: Additional cycles of gemcitabine begin approximately 4 weeks after completion of radiation therapy.
Also known as: 2-Deoxy-2, 2-difluorocytidine monohydrochloride, Gemzar
Overall Survival Time
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.
Time frame: assessed every 3 months for 2 years, then every 6 months for year 3
Progression-free Survival Time
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.
Time frame: assessed every 3 months for 2 years, then every 6 months for year 3
Overall Response
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.
Time frame: assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3
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.
| Milestone | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| Started | 38 | 36 |
| Eligible | 37 | 34 |
| Began protocol therapy | 35 | 34 |
| Eligible and treated | 34 | 34 |
| Completed | 9 | 9 |
| Not completed | 29 | 27 |
| Withdrew: Adverse event | 8 | 8 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Withdrew: Lack of efficacy | 10 | 8 |
| Withdrew: Ineligible | 1 | 2 |
| Withdrew: Other reason | 2 | 2 |
| Withdrew: Other complicating disease | 1 | 0 |
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.
| Months | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| Overall Survival Time | 9.2 (7.9 to 11.4) | 11.0 (7.6 to 15.5) |
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.
| Months | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| Progression-free Survival Time | 6.7 (3.9 to 8.7) | 6.0 (5.4 to 8.4) |
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.
| participants | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| Overall Response | 2 | 2 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gemcitabine | — | 28/35 (80%) | 5/35 (14.3%) |
| Gemcitabine + Radiation | — | 28/34 (82.4%) | 2/34 (5.9%) |
| Event | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| NeutropheniaInvestigations | 14/35 | 14/34 |
| LeukopeniaInvestigations | 5/35 | 11/34 |
| FatigueGeneral disorders | 2/35 | 11/34 |
| NauseaGastrointestinal disorders | 3/35 | 10/34 |
| VomitingGastrointestinal disorders | 3/35 | 9/34 |
| ThrombocytopeniaInvestigations | 2/35 | 7/34 |
| AnemiaBlood and lymphatic system disorders | 2/35 | 6/34 |
| Transfusion:PRBCSBlood and lymphatic system disorders | 2/35 | 6/34 |
| AnorexiaMetabolism and nutrition disorders | 1/35 | 6/34 |
| HypoalbuminemiaMetabolism and nutrition disorders | 0/35 | 3/34 |
| Event | Gemcitabine | Gemcitabine + Radiation |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 4/35 | 1/34 |
| NauseaGastrointestinal disorders | 3/35 | 2/34 |
| Weight lossGeneral disorders | 2/35 | 1/34 |
| VomitingGastrointestinal disorders | 2/35 | 1/34 |
| Age, Continuous(years) | Gemcitabine | Gemcitabine + Radiation | Total |
|---|---|---|---|
| Mean | 67.0 ± 8.7 | 65.3 ± 10.3 | 66.2 ± 9.5 |
| Sex: Female, Male(Participants) | Gemcitabine | Gemcitabine + Radiation | Total |
|---|---|---|---|
| Female | 19 | 15 | 34 |
| Male | 18 | 19 | 37 |
| Region of Enrollment(participants) | Gemcitabine | Gemcitabine + Radiation | Total |
|---|---|---|---|
| United States | 37 | 34 | 71 |
Showing the first 100 of 229 sites across 2 countries.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eastern Cooperative Oncology Group