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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRajiv Gandhi Cancer Institute & Research Center, India

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • neoadjuvant chemotherapy
  • curative surgery

Treatment groups

114 Participants
are divided into 2 treatment groups