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

NCT00304135 | Completed Phase 2 DMC

• 5 other identifiers: CDR0000470411FFCD-9902SANOFI-FFCD-9902LILLY-FFCD-9902FFCD-FNCLCC-SFRO-9902
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 20

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.

Conditions

Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer

Keywords

localized unresectable adult primary liver cancer; unresectable extrahepatic bile duct cancer; unresectable gallbladder cancer

Outcome Measures

Primary Outcomes (2)

• Progression rate at 3 months

  2012

• Overall survival

  2012

Secondary Outcomes (2)

• Toxicity

  2012

• Biliary complication rate

  2012

Study Arms (2)

Radio-chimiothérapie

ACTIVE COMPARATOR

Radio-chimiothérapie

Drug: cisplatin

GEMOX

EXPERIMENTAL

GEMOX

Drug: gemcitabine hydrochloride; Drug: oxaliplatin

Interventions

cisplatin DRUG

Radio-chimiothérapie

gemcitabine hydrochloride DRUG

GEMOX

oxaliplatin DRUG

GEMOX

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (20)

Centre Hospitalier General

Belfort, 90000, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Centre Hospitalier de Dax

Dax, 40100, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

C. H. Du Mans

Le Mans, 72037, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital Sebastopol, C.H.U. de Reims

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35062, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, 21140, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier de Tarbes

Tarbes, 65013, France

Location

Related 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 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.

  PMID: 25241229 RESULT

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Liver Neoplasms

Interventions

Cisplatin; Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Bruno Chauffert

  Centre Georges Francois Leclerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: October 1, 2005
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 30, 2016

Record last verified: 2006-12

Locations

FR (20)