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
Rajiv Gandhi Cancer Institute & Research Center, India
114 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
Summary
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria10
- 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
Interventions
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
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)
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NCT06712420