Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC

PHASE3CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

October 10, 2024

Study Completion Date

October 10, 2024

Conditions
Incidental Gallbladder CarcinomaBiliary Tract Cancer
Interventions
DRUG

Gemcitabine

Gemcitabine (1000 mg/m2) in 250-500 ml 0.9% saline every three weeks on days 1 and 8 intravenously

DRUG

Cisplatin

Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously, in 1000 ml 0.9% saline with KCl 20 mmol and MgSO4 8 mmol during the one hour cisplatin infusion followed by 500 ml 0.9% saline over 30 minutes prior to gemcitabine; with adequate pre- and posthydration

PROCEDURE

Oncologically radical margin-free (R0) resection

Oncologically radical margin-free (R0) resection

DRUG

Adjuvant chemotherapy

Can be selected by Investigator's Choice

Trial Locations (1)

60488

Krankenhaus Nordwest gGmbH, Frankfurt

Sponsors
All Listed Sponsors
collaborator

German Research Foundation

OTHER

lead

Krankenhaus Nordwest

OTHER