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Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

NCT02170090 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 789

Last updated 2025-03-30

No results posted yet for this study

Summary

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.

Conditions

Interventions

DRUG

Gemcitabine

Gemcitabine 1000mg/m2

DRUG

Cisplatin

Cisplatin 25mg/m2

DRUG

Capecitabine

Capecitabine 1250mg/m2

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • Dutch Cancer Society

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Henning Wege · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Australia
  • Austria
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02170090 on ClinicalTrials.gov