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

Phase 3

Not yet recruiting

• Conditions: Gall Bladder Carcinoma
• Interventions: Procedure: curative surgery; Drug: neoadjuvant chemotherapy

• Registration Number: NCT06712420
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

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.

Study Timeline

• Study First Submitted: 2024-10-22
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study Start: 2024-12
• Study First Posted: 2024-12-02
• Last Update Posted: 2024-12-02
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
upfront surgery	curative surgery	after staging workup and biopsy, patient being taken up for upfront 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
Neoadjuvant chemotherapy followed by surgery	neoadjuvant chemotherapy	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.
Neoadjuvant chemotherapy followed by surgery	curative surgery	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
post operative outcomes	90 days	To compare mortality and morbidity rate in two groups

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 Delhi, India