Chemotherapy before surgery for advanced gallbladder cancer
Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial
This study tests if giving chemotherapy before surgery can help people with advanced gallbladder cancer have better treatment results compared to having surgery right away.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rajiv Gandhi Cancer Institute & Research Center, India Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Delhi, National Capital Territory of Delhi and 2 other locations) |
| Trial ID | NCT06712420 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of neoadjuvant chemotherapy in patients with locally advanced gallbladder cancer compared to immediate surgical intervention. The study aims to determine if administering chemotherapy prior to surgery can lead to better tumor downstaging, increased rates of successful surgical resection, and improved survival outcomes. Participants will be randomized to receive either chemotherapy followed by surgery or surgery alone. The trial seeks to fill a gap in knowledge regarding the role of chemotherapy in this aggressive cancer type.
Who should consider this trial
Good fit: Ideal candidates include patients with locally advanced resectable gallbladder cancer who meet specific clinical criteria.
Not a fit: Patients with early-stage gallbladder cancer or those with significant complications such as distant metastasis or vascular involvement may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and survival rates for patients with locally advanced gallbladder cancer.
How similar studies have performed: While neoadjuvant chemotherapy has been explored in other cancers, its application in gallbladder cancer is novel and has not been previously evaluated in randomized clinical trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Delhi, National Capital Territory of Delhi and 2 other locations
- Rajiv Gandhi Cancer Institute and Research Centre — Delhi, National Capital Territory of Delhi, India (Recruiting)
- Rajiv Gandhi Cancer Institute and Research Centre — Delhi, National Capital Territory of Delhi, India (Recruiting)
- Rajiv Gandhi Cancer Institute and Research Centre — Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Shivendra Singh, Mch
- Email: shiven_24@yahoo.co.in
- Phone: +919818975024
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.