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

Summary

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

Eligibility

Inclusion Criteria:

* 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 Criteria:

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

Conditions2

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