Status:
COMPLETED
Gemcitabine With or Without Combination Chemotherapy and Radiation Therapy in Treating Patients With Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
Up to 120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, fluorouracil, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with nonresectable, nonmetastatic adenocarcinoma of the pancreas treated with gemcitabine hydrochloride with vs without fluorouracil, c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- No neuroendocrine or other histologies
- No extra-abdominal metastases
- No hepatic or peritoneal metastases by celioscopy
- Peritoneal carcinomatous (cytology positive by peritoneal lavage) may be allowed
- Nonresectable disease meeting ≥ 1 of the following criteria:
- Arterial invasion
- Mesenteric-portal vein invasion \> 15 mm and or less than hemicircumference
- Satellite adenopathies encompassed in the radiation field
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Bilirubin \< 1.75 mg/dL
- Creatinine \< 1.5 mg/dL
- WBC \> 1,500/mm³
- Platelet count \> 100,000/mm³
- No major organ disorder, including cardiac or coronary insufficiency
- Prothrombin time \> 80%
- No psychiatric or social condition that would preclude study therapy
- No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No contraindications to radiotherapy or chemotherapy
- No intractable pancreatic pain not relieved by morphine and/or analgesic radiotherapy
- PRIOR CONCURRENT THERAPY:
- No prior adjuvant or palliative chemotherapy or radiotherapy
- Prior surgical diversion of the biliary and/or digestive tract allowed
Exclusion
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00416507
Start Date
March 1 2000
End Date
January 1 2007
Last Update
May 30 2016
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