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

NCT ID: NCT00304135

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2012-12-31

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 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.

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 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.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radio-chimiothérapie

Radio-chimiothérapie

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

GEMOX

GEMOX

Group Type: EXPERIMENTAL

gemcitabine hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

oxaliplatin

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno Chauffert

Role: PRINCIPAL_INVESTIGATOR

Centre Georges Francois Leclerc

Locations

Centre Hospitalier General

Belfort, , France

Centre Hospitalier Pierre Oudot

Bourgoin, , France

Hopital Louis Pasteur

Colmar, , France

Centre Hospitalier de Dax

Dax, , France

Hopital Du Bocage

Dijon, , France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, , France

Centre Hospitalier Departemental

La Roche-sur-Yon, , France

C. H. Du Mans

Le Mans, , France

CHU de la Timone

Marseille, , France

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, , France

CHR D'Orleans - Hopital de la Source

Orléans, , France

Hopital Bichat - Claude Bernard

Paris, , France

CHU Pitie-Salpetriere

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Hopital Sebastopol, C.H.U. de Reims

Reims, , France

Centre Eugene Marquis

Rennes, , France

Hopital Charles Nicolle

Rouen, , France

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, , France

Hopital Universitaire Hautepierre

Strasbourg, , France

Centre Hospitalier de Tarbes

Tarbes, , France

Countries

France

References

Phelip JM, Vendrely V, Rostain F, Subtil F, Jouve JL, Gasmi M, Michel P, Le Malicot K, Smith D, Seitz JF, Fauchart JP, Martin P, Bennouna J, Morin T, Bonnet I, Maingon P, Lepage C, Chauffert B. Gemcitabine plus cisplatin versus chemoradiotherapy in locally advanced biliary tract cancer: Federation Francophone de Cancerologie Digestive 9902 phase II randomised study. Eur J Cancer. 2014 Nov;50(17):2975-82. doi: 10.1016/j.ejca.2014.08.013. Epub 2014 Sep 17.

Reference Type: RESULT

PMID: 25241229 (View on PubMed)

Other Identifiers

FFCD-9902

Identifier Type: -

Identifier Source: secondary_id

SANOFI-FFCD-9902

Identifier Type: -

Identifier Source: secondary_id

LILLY-FFCD-9902

Identifier Type: -

Identifier Source: secondary_id

FFCD-FNCLCC-SFRO-9902

Identifier Type: -

Identifier Source: secondary_id

CDR0000470411

Identifier Type: -

Identifier Source: org_study_id