Overview

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

Status:
Recruiting

Trial end date:
2024-04-01

Target enrollment:

Participant gender:

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 including an embedded sub-study for R1 resected patients receiving additional chemoradiation.

Phase:

Phase 3

Details

Lead Sponsor:

Universitätsklinikum Hamburg-Eppendorf

Collaborators:

AGITG Australasian Gastro Intestinal Trials Group
Australasian Gastro-Intestinal Trials Group
Cancer Research UK
Deutsche Krebshilfe e.V., Bonn (Germany)
Dutch Cancer Society
KWF Kanker Bestrijding The Netherlands
medac GmbH

Treatments:

Capecitabine
Cisplatin
Gemcitabine