Comparing systemic therapy with and without radiation for unresectable 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 aims to evaluate the effectiveness of adding radiation therapy to systemic chemotherapy in patients with unresectable gallbladder cancer. Participants will be randomly assigned to receive either systemic therapy alone or systemic therapy combined with radiation therapy. The study will assess overall survival, cancer-free intervals, side effects, and quality of life outcomes. The trial is particularly relevant given the high incidence of gallbladder cancer in India and the limited evidence on optimal treatment strategies for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven (biopsy/cytology) adenocarcinoma of gall bladder. Gall bladder neck primaries with hilar block mimicking hilar cholangiocarcinoma will also be included.
* Non metastatic at presentation as determined using cross sectional imaging and diagnostic laparoscopy if done as a part of standard work up recommended in the joint clinic.
* Locally advanced disease with one or more of the following
* Extensive liver infiltration not amenable for surgery but feasible for safe radiation delivery (Liver minus gross tumor volume at least 700cc)
* Vascular involvement: encasement (\>180-degree angle) of one of the vessels: Hepatic artery, main portal vein, right or left portal vein
* Obstructive jaundice with hilar involvement (type 2 non communicating block and higher blocks as per Bismuth-Corlette classification)
* Stable disease or partial response (RECIST 1.1) after initial 3 months of Gemcitabine based chemotherapy
* More than 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 fit for chemotherapy
* Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy
* Hematological- Hb\> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L.
* Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g/L
* Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance \>= 50 mL/min

Exclusion Criteria:

* Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded.
* Prior abdominal therapeutic radiation
* Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
* Pregnancy/Lactating women

Where it's running

• Tata Memorial Centre
  Mumbai, Maharashtra, India Recruiting

Study contacts

• Principal investigator: Shivakumar Gudi, MD — Assistant Professor, Radiation Oncology
• Study coordinator: Shivakumar Gudi, MD
• Email: shivakumargudi@gmail.com
• Phone: +912224177000

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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.