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Home > "G" Clinical Trials Conditions > Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer  Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
For Condition: stage 2 pancreatic cancer,stage 3 pancreatic cancer,stage 1 pancreatic cancer,adenocarcinoma of the pancreas
Status: Recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group , EORTC Radiotherapy Cooperative Group,Federation Francophone de Cancerologie Digestive
Synopsis: RATIONALE: Drugs used in chemotherapy such as gemcitabine use 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. Combining gemcitabine with radiation therapy may kill any tumor cells remaining after surgery. It is not yet known whether gemcitabine combined with radiation therapy is more effective than no further therapy following surgery in treating patients who have pancreatic cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of gemcitabine combined with radiation therapy with that of observation alone in treating patients who have undergone surgery for pancreatic cancer.
Details: OBJECTIVES: Phase II: - Determine the feasibility of gemcitabine and radiotherapy after prior curative resection in patients with pancreatic head adenocarcinoma. - Determine the tolerability of this regimen, in terms of acute and late toxicity, in these patients. Phase III: - Compare the disease-free and overall survival of patients treated with gemcitabine and radiotherapy vs observation. - Compare the quality of life of patients treated with this regimen vs observation. - Determine the toxicity of this regimen in these patients. - Determine the sites of recurrence in patients treated with this regimen vs observation. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG/WHO performance status (0-1 vs 2), participating center, and N stage (N0 vs N1 vs NX). Patients are randomized to 1 of 2 treatment arms. - Within 8 weeks after prior surgical resection, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients then receive additional gemcitabine IV over 30 minutes on days 57, 64, 71, 78, 85, and 92. Beginning on day 57, patients also undergo radiotherapy once daily, 5 days a week, for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. - Arm II: Patients are observed and receive no further treatment. Quality of life (QOL) is assessed in both arms, according to the following schedules: - Arm I: QOL is assessed at baseline; after 2 courses of chemotherapy; at 3 weeks after the beginning of chemoradiotherapy; after the completion of chemoradiotherapy; every 3 months for 2 years; and then every 6 months for 1 year. - Arm II: QOL is assessed at baseline; at 8 weeks after randomization; on days 78 and 112; every 3 months for 2 years; and then every 6 months for 1 year. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 538 patients (269 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed pancreatic head adenocarcinoma - Prior pancreaticoduodenectomy required - Documented histological examination of surgical margins (R0), including retroperitoneal margin - Performed within the past 8 weeks - Any number of lymph nodes (less than 10 OR 10 or more) allowed - No periampullary cancer PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - WHO 0-2 Life expectancy - Not specified Hematopoietic - WBC greater than 3,500/mm^3 - Platelet count greater than 150,000/mm^3 - Hemoglobin greater than 9.0 g/dL Hepatic - Bilirubin less than 1.5 times normal - AST and ALT less than 3.0 times normal Renal - Creatinine less than 1.2 mg/dL Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics - Recovered from prior surgery Other - No other concurrent anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VolkerBudach, Study Chair, Universitaetsklinikum Charite
Centre Hospitalier Peltzer-La Tourelle *Recruiting*
Verviers, , B-4800
Belgium
Recruiting Contact Person 32-87-212-111
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-2-555-3111
Cazk Groeninghe - Campus St-Niklaas *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-56-242-590
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE, , B-4000
Belgium
Recruiting Contact Person 32-4-366-7111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Additional Information:
Study ID Numbers: CDR0000310131; EORTC-40013,FFCD-EORTC-40013,EORTC-22012
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064207
Other Stage 1 Pancreatic Cancer Studies:
1. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
2. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
3. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
4. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
5. Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
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Other stage 1 pancreatic cancer Clinical Trials
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Gemcitabine and Radiation Therapy Compared With Observation in Treating Patients Who Have Undergone Surgery for Pancreatic Cancer
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