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Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Summary
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Official title: Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2025-01-01
Completion Date
2028-12
Last Updated
2025-04-16
Healthy Volunteers
No
Conditions
Interventions
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
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
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