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

Phase 3 Active not recruiting 789 enrolled University Medical Center Hamburg-Eppendorf Australasian Gastro-Intestinal Trials Group · collab Cancer Research UK · collab Deutsche Krebshilfe e.V., Bonn (Germany) · collab Dutch Cancer Society · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-04
Primary completion: 2025-12
Completion: 2025-12

Publications

Stein A, Arnold D, Bridgewater J, Goldstein D, Jensen LH, Klumpen HJ, Lohse AW, Nashan B, Primrose J, Schrum S, Shannon J, Vettorazzi E, Wege H. Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial. BMC Cancer. 2015 Jul 31;15:564. doi: 10.1186/s12885-015-1498-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	1250 mg/m2	—
Subject	Cisplatin	Other / unclassified	25 mg/m2	—
Subject	Gemcitabine	Small molecule	1000 mg/m2	—

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

Summary

Timeline

Publications

Drugs

Indications