Chemotherapy before surgery for advanced gallbladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.