Actively Recruiting
Radiation Therapy in Unresectable Gall Bladder Cancer
Led by Tata Memorial Centre · Updated on 2025-04-11
249
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare two treatment regimes, namely, systemic therapy (chemotherapy and/or immunotherapy) alone vs. systemic therapy and radiation therapy in patients with inoperable but localized gallbladder cancer. The main questions it aims to answer are: * Whether adding radiation therapy to systemic therapy improves overall survival? * What are the effects on other endpoints like cancer-free intervals, side effects, and quality of life? Participants will be randomly assigned to one of the two treatment regimes mentioned earlier by a computer-based program. Researchers will compare survival and quality of life outcomes between the two groups.
CONDITIONS
Official Title
Radiation Therapy in Unresectable Gall Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed adenocarcinoma of the gallbladder, including gallbladder neck tumors with hilar block
- No distant metastasis at diagnosis based on imaging and laparoscopy if performed
- Locally advanced disease with extensive liver involvement suitable for radiation or vascular involvement as specified
- Obstructive jaundice with certain types of hilar involvement
- Stable disease or partial response after 3 months of gemcitabine-based chemotherapy
- Age 18 years or older
- ECOG performance status 0, 1, or 2 suitable for chemotherapy
- Adequate hematological, liver, and kidney function within specified laboratory limits
You will not qualify if you...
- Presence of distant metastases, including nonregional lymph nodes
- Prior abdominal radiation therapy
- History of other cancers not cured or without disease-free period of over 5 years, except certain skin and cervical cancers
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012
Actively Recruiting
Research Team
S
Shivakumar Gudi, MD
CONTACT
R
Reena Engineer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here