Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)

PHASE3RecruitingINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

December 31, 2028

Conditions
Gall Bladder Carcinoma
Interventions
DRUG

neoadjuvant chemotherapy

NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0. PAtients will undergo curative surgery after neoadjuvant chemotherapy

PROCEDURE

curative surgery

Patient being taken up for surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification

Trial Locations (3)

110085

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre, Delhi

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre, Delhi

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre, Delhi

All Listed Sponsors
lead

Rajiv Gandhi Cancer Institute & Research Center, India

OTHER