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

NCT06712420 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: RGCIRC/IRB-BHR/26/2024RES/SCM/61/2023/89
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief Summary

to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly

Conditions

Gall Bladder Carcinoma

Keywords

gallbladder, locally advanced, neoadjuvant

Outcome Measures

Primary Outcomes (1)

• improvement in 3 year overall survival

  To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer

  3 year

Secondary Outcomes (1)

• post operative outcomes

  90 days

Study Arms (2)

upfront surgery

EXPERIMENTAL

after staging workup and biopsy, patient being taken up for upfront 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

Procedure: curative surgery

Neoadjuvant chemotherapy followed by surgery

EXPERIMENTAL

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.

Drug: neoadjuvant chemotherapy; Procedure: curative surgery

Interventions

neoadjuvant chemotherapy DRUG

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

Also known as: NACT

Neoadjuvant chemotherapy followed by surgery

curative surgery PROCEDURE

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

Neoadjuvant chemotherapy followed by surgery; upfront surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG 0-2
• Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.
• Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.

You may not qualify if:

• Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging .
• Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy.
• Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging.
• Obstructive jaundice due to involvement of biliary tree by tumour.
• Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein.
• Any distant metastasis or isolated port site metastasis
• Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN).
• Poor performance status ECOG 3 or more.
• Pregnancy.
• Inability or unwillingness to follow study protocol

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (3)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, 110085, India

RECRUITING

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Shivendra Singh, Mch Surgical gastroenterology

  Rajiv Gandhi Cancer Institute and Research Centre

  STUDY DIRECTOR

Central Study Contacts

Shivendra Singh, Mch

CONTACT

+919818975024; shiven_24@yahoo.co.in

Shaifali Goel, DrNB

CONTACT

+918368382060; doctor.shaifali@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: December 2, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (3)