RecruitingPhase 3NCT06712420

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

Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Enrollment

114 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Gall Bladder Carcinoma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled trial tests whether giving chemotherapy before surgery (neoadjuvant chemotherapy) improves outcomes for patients with locally advanced gallbladder cancer. **You may be eligible if...** - You are in good overall health (ECOG 0–2) - You have locally advanced but potentially removable gallbladder cancer (clinical T3/T4 or with nearby lymph node involvement on imaging) - You had a previous cholecystectomy (gallbladder removal) with residual disease, bile spillage, or piecemeal removal **You may NOT be eligible if...** - Your gallbladder cancer is early-stage (T1/T2) without lymph node involvement - Your cancer requires removing a large portion of the liver or pancreas (major hepatectomy or Whipple procedure) - You have jaundice caused by tumor blockage of the bile duct - Your cancer involves major blood vessels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant 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

PROCEDUREcurative 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

Locations(3)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, National Capital Territory of Delhi, India

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NCT06712420