NCT00416507CompletedPhase 3
Non Resectable But Non Metastatic Adenocarcinoma of the Exocrine Pancreas Non Resecables. Randomised Phase III: Initial Radiochimiotherapy (5-FU, Cisplatine, 60 GY Radiotherapy) Followed by Gemcitabine Versus Gemcitabine Alone
Federation Francophone de Cancerologie Digestive0 sites190 target enrollmentStarted: March 1, 2000Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 190
Study Overview
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 dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective for pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine alone in treating patients with nonmetastatic pancreatic cancer that cannot be removed by surgery.
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, cisplatin, and radiotherapy followed by gemcitabine hydrochloride.
Secondary
- Compare the toxicities of these regimens in these patients.
- Compare the objective response (complete, partial, or stable) in patients treated with these regimens.
- Compare the clinical benefit, in terms of general condition and weight maintenance in patients treated with these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- — to 120 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Investigators
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