Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery

Federation Francophone de Cancerologie Digestive

Status and phase: Completed; Phase 3; Phase 2

Conditions: Gallbladder Cancer; Extrahepatic Bile Duct Cancer; Liver Cancer

Treatments: Drug: cisplatin; Drug: gemcitabine hydrochloride; Drug: oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00304135

CDR0000470411

FFCD-9902

SANOFI-FFCD-9902

FFCD-FNCLCC-SFRO-9902

LILLY-FFCD-9902

Details and patient eligibility

About

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 stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving fluorouracil and cisplatin together with radiation therapy is more effective than giving gemcitabine together with oxaliplatin in treating nonmetastatic biliary tract cancer.

PURPOSE: This randomized phase II/III trial is studying fluorouracil, cisplatin, and radiation therapy to see how well they work compared to gemcitabine and oxaliplatin in treating patients with nonmetastatic biliary tract cancer that cannot be removed by surgery.

Full 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 gemcitabine hydrochloride and oxaliplatin. (phase II)
• Compare the overall survival of patients treated with these regimens. (phase III)

Secondary

• Compare toxicities of these regimens in these patients. (phase II)
• Compare the quality of life at initial drainage (phase II) and overall (phase III) of patients treated with these regimens.
• Compare the biliary complication rate in patients treated with these regimens.
• Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease location (gallbladder vs intrahepatic biliary duct vs extrahepatic biliary duct). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiotherapy once daily, 5 days a week on days 1-33. Patients also receive fluorouracil IV continuously over 5 days once a week in weeks 1-5 and cisplatin IV over 15 minutes on days 1-4 and 29-32 (or days 1 or 2 and 29 or 30) in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months thereafter.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 170 patients will be accrued for this study.

Enrollment: 34 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Radio-chimiothérapie

Active Comparator group

Description:

Radio-chimiothérapie

Treatment:

Drug: cisplatin

GEMOX

Experimental group

Description:

GEMOX

Treatment:

Drug: oxaliplatin

Drug: gemcitabine hydrochloride