Gemcitabine Hydrochloride and Oxaliplatin or Observation in Treating Patients With Biliary Tract Cancer That Has Been Removed by Surgery

Phase 3

Completed

• Conditions: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer
• Interventions: Drug: gemcitabine hydrochloride; Other: clinical observation; Drug: oxaliplatin; Procedure: adjuvant therapy; Procedure: quality-of-life assessment

• Registration Number: NCT01313377
• Lead Sponsor: UNICANCER

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Observation is watching a patient's condition but not giving treatment until symptoms appear. It is not yet known whether giving gemcitabine hydrochloride together with oxaliplatin is more effective than observation in treating patients with biliary tract cancer that has been removed by surgery.

PURPOSE: This randomized phase III trial is studying giving gemcitabine hydrochloride together with oxaliplatin to see how well it works compared with observation in treating patients with biliary tract cancer that has been removed by surgery.

Detailed Description

OBJECTIVES:

Primary

* Compare disease-free survival (DFS) of patients with resected biliary tract cancer treated with adjuvant gemcitabine hydrochloride and oxaliplatin versus clinical observation.

* Compare quality of life of these patients.

Secondary

* Compare overall survival of these patients.

* Determine the toxicity of the chemotherapy in these patients.

* Explore prognostic factors for DFS including resection result (R0 vs R1), location of primary tumor (intrahepatic vs extrahepatic vs gallbladder), evolution of CA19-9, and lymph node involvement (N0 vs N+ and Nx). (Exploratory)

* Study pathological factors in surgical specimens to identify main characteristics and phenotypic clinicoanatomical biliary tract cancers before therapy. (Exploratory)

* Identify nontumor-associated liver injury and factors that may facilitate the emergence of biliary tract cancers. (Exploratory)

* Identify signaling pathways that may predict response to therapy. (Exploratory)

* Determine the molecular characteristics to differentiate tumors according to their position in the biliary tract (extrahepatic bile duct, intrahepatic cholangiocarcinoma site \[hilar\], and peripheral cholangiocarcinoma vesicle site). (Exploratory)

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 14 days for 12 courses.

* Arm II: Patients undergo clinical observation only every 4 weeks for 5 months. Quality of life is assessed at baseline, at 3 and 6 months, and then at all follow-up visits.

After completion of study therapy, patients are followed up at 6 months, every 3 months for 2 years, and then every 6 months for 3 years.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A: Gemox 85	gemcitabine hydrochloride	Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
ARM A: Gemox 85	oxaliplatin	Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
ARM A: Gemox 85	adjuvant therapy	Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
ARM A: Gemox 85	quality-of-life assessment	Adjuvant chemotherapy for six months with gemcitabine - oxaliplatin 85mg / m² ( GEMOX 85)
ARM B:	clinical observation	Observation until progression or death
ARM B:	quality-of-life assessment	Observation until progression or death

Primary Outcome Measures

Name	Time	Method
Disease-free survival	up to 3 years
Quality of life	up to 3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	up to 3 years
Toxicity of adjuvant chemotherapy	up to 3 years

Trial Locations

Locations (37)

CHU - Hôpital Nord; 🇫🇷 Amiens, France

Centre Paul Papin; 🇫🇷 Angers, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

Hôpital Jean Minjoz; 🇫🇷 Besancon, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CHU Brest - Hôpital Morvan; 🇫🇷 Brest, France

CHU Côte de Nacre; 🇫🇷 Caen, France

CHU Estaing; 🇫🇷 Clermont Ferrand, France

Hôpital Beaujon; 🇫🇷 Clichy, France

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