Clinical trial NCT06712420: Neoadjuvant Chemotherapy for Locally Advanced Gall Bladder Cancer : a Randomized Control Trial (NEOGB)
Official title: Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gall Bladder Carcinoma
Keywords: gallbladder, locally advanced, neoadjuvant
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer.

The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial.

Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.

Eligibility criteria: 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

Primary outcomes:
measure: improvement in 3 year overall survival
timeFrame: 3 year
Secondary outcomes:
measure: post operative outcomes
timeFrame: 90 days
Other outcomes:
Locations:
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
Study officials:
affiliation: Rajiv Gandhi Cancer Institute and Research Centre
name: Shivendra Singh, Mch Surgical gastroenterology
role: STUDY_DIRECTOR
References: