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

NCT06712420 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-04-16

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • Rajiv Gandhi Cancer Institute & Research Center, India

    lead OTHER

Principal Investigators

  • Shivendra Singh, Mch Surgical gastroenterology · Rajiv Gandhi Cancer Institute and Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-04-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06712420 on ClinicalTrials.gov