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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • neoadjuvant chemotherapy

    Drug

    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

    Procedure/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

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: upfront surgeryExperimental treatment 1 intervention
Group B: Neoadjuvant chemotherapy followed by surgeryExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

improvement in 3 year overall survival

To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer

Time frame
3 year

Secondary outcomes

1

post operative outcomes

To compare mortality and morbidity rate in two groups

Time frame
90 days

Other outcomes

Sponsors and contacts

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