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

Liver Cancer Clinical Trial

Official title:

Randomized Phase II-III Study of Chemoradiation With Fluorouracil and Cisplatin Versus Chemotherapy (Gemcitabine/Oxaliplatin) in Non Resectable But Non Metastatic Cancer of the Biliary Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304135
• Other study ID #: CDR0000470411
• Secondary ID: FFCD-9902SANOFI-
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 15, 2006
• Last updated: May 27, 2016
• Start date: October 2005
• Est. completion date: December 2012

Study information

• Verified date: December 2006
• Source: Federation Francophone de Cancerologie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Hospitalier General	Belfort
France	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu
France	Hopital Louis Pasteur	Colmar
France	Centre Hospitalier de Dax	Dax
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Hopital Du Bocage	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	Orleans
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
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

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (1)

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 locall — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression rate at 3 months		2012	No
Primary	Overall survival		2012	No
Secondary	Toxicity		2012	Yes
Secondary	Biliary complication rate		2012	No