Status:
COMPLETED
Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, cisplatin, oxaliplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppi...
Detailed Description
OBJECTIVES: Primary * Compare the 3-month progression rate in patients with unresectable, nonmetastatic cancer of the biliary tract treated with fluorouracil, cisplatin, and radiotherapy vs gemcitab...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of cancer of the biliary tract by 1 of the following methods:
- Histologic confirmation
- Stenosis of the biliary tract by MRI, CT scan, or ECHO
- Unresectable disease
- Amenable to radiotherapy
- No visceral metastases by imaging
- Hepatic adenopathies that can be included in a radiation field allowed
- No known ampulla of Vater or pancreatic cancer involving the biliary tract
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Creatinine \< 1.5 mg/dL
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 75,000/mm\^3
- Prothrombin time \> 70%
- Bilirubin ≤ 2.9 mg/dL (after hepatic draining, if needed)
- No unstable angina
- No symptomatic cardiac insufficiency
- No other comorbidity that would preclude study therapy
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No prior hydatid cyst or alveolar echinococciasis
- Not pregnant or nursing
- PRIOR CONCURRENT THERAPY:
- No recent biliary surgery
- No hepatic intra-arterial chemotherapy
- No prior anticancer therapy
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00304135
Start Date
October 1 2005
End Date
December 1 2012
Last Update
May 30 2016
Active Locations (20)
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1
Centre Hospitalier General
Belfort, France, 90000
2
Centre Hospitalier Pierre Oudot
Bourgoin, France, 38300
3
Hopital Louis Pasteur
Colmar, France, 68024
4
Centre Hospitalier de Dax
Dax, France, 40100