Clinical trial NCT00304135: Fluorouracil, Cisplatin, and Radiation Therapy or Gemcitabine and Oxaliplatin in Treating Patients With Nonmetastatic Biliary Tract Cancer That Cannot Be Removed By Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Liver Cancer
Keywords: localized unresectable adult primary liver cancer
unresectable extrahepatic bile duct cancer
unresectable gallbladder cancer
Lead sponsor: Federation Francophone de Cancerologie Digestive
Sponsor class: OTHER
First posted: 2006-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Progression rate at 3 months
timeFrame: 2012
measure: Overall survival
timeFrame: 2012
Secondary outcomes:
measure: Toxicity
timeFrame: 2012
measure: Biliary complication rate
timeFrame: 2012
Other outcomes:
Locations:
city: Belfort
country: France
facility: Centre Hospitalier General
city: Bourgoin-Jallieu
country: France
facility: Centre Hospitalier Pierre Oudot
city: Colmar
country: France
facility: Hopital Louis Pasteur
city: Dax
country: France
facility: Centre Hospitalier de Dax
city: Dijon
country: France
facility: Hopital Du Bocage
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: Le Mans
country: France
facility: C. H. Du Mans
city: Marseille
country: France
facility: CHU de la Timone
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier General de Mont de Marsan
city: Orleans
country: France
facility: CHR D'Orleans - Hopital de la Source
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Hopital Sebastopol, C.H.U. de Reims
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Semur en Auxois
country: France
facility: Centre Hospitalier de Semur en Auxois
city: Strasbourg
country: France
facility: Hopital Universitaire Hautepierre
city: Tarbes
country: France
facility: Centre Hospitalier de Tarbes
Study officials:
affiliation: Centre Georges Francois Leclerc
name: Bruno Chauffert
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.