NCT03673072

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

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 (ICC/ECC) - A Phase III Study of the German Registry of Incidental Gallbladder Carcinoma Platform (GR) - The AIO/ CALGP/ ACO- GAIN-Trial -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 (ICC/ECC)

Detailed description

The aim of the study is to investigate whether induction chemotherapy followed by radical re-resection (and - if possible - postoperative chemotherapy) in incidental gallbladder carcinoma (IGBC) or in front radical resection in biliary tract cancer (BTC) (intrahepatic cholangiocarcinoma (ICC)/ extrahepatic cholangiocarcinoma (ECC)) prolongs overall survival without impaired quality of life compared to immediate radical surgery alone with or without adjuvant chemotherapy (investigator's choice) in patients with IGBC, or BTC (ICC/ECC). One of the most important secondary objectives is to raise awareness for the necessity of a radical second surgery as well as to improve the adherence to the treatment guidelines in IGBC. Further secondary objectives are safety and tolerability of the treatment as well as quality of life.

Conditions

• Incidental Gallbladder Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-10-10
• Completion: 2024-10-10
• First posted: 2018-09-17
• Last updated: 2024-11-12

Locations

1 site across 1 country: Germany