Comparing systemic therapy with and without radiation for unresectable gallbladder cancer
Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2/3 Integrated Randomized Clinical Trial
PHASE2; PHASE3 · Tata Memorial Centre · NCT06214572
This study is testing whether adding radiation therapy to chemotherapy can help people with unresectable gallbladder cancer live longer and feel better.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 249 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tata Memorial Centre (other) |
| Drugs / interventions | chemotherapy, radiation, immunotherapy |
| Locations | 1 site (Mumbai, Maharashtra) |
| Trial ID | NCT06214572 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed unresectable gallbladder cancer who have stable disease after initial chemotherapy.
Not a fit: Patients with metastatic gallbladder cancer or those who do not respond to initial systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve overall survival and quality of life for patients with unresectable gallbladder cancer.
How similar studies have performed: While the role of radiation therapy in this setting has not been extensively evaluated in phase 3 trials, preliminary nonrandomized data suggests potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Mumbai, Maharashtra
- 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
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.
Conditions: Gall Bladder Cancer, Biliary tract cancer, Radiation therapy, Unresectable