Tests chemotherapy with or without radiation for inoperable gallbladder cancer
Compares chemotherapy alone with chemotherapy plus radiation in adults with gallbladder cancer.
Plain-language title generated from the registry record
Registry title: Radiation Therapy in Unresectable Gall Bladder Cancer
Key facts
- Where
- Mumbai, IndiaSee the site
- Phase
- Phase 2/3
Where in India
- Tata Memorial CentreMumbai, IndiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tata Memorial Centre
- Trial code
- NCT06214572
- Record updated
- 11 April 2025
- Original description
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:Read full original descriptionShow less
Systemic Therapy With or Without Radiation Therapy in Unresectable Nonmetastatic Gall Bladder Carcinoma: Open Label, Parallel Arm, Phase 2/3 Integrated Randomized Clinical Trial
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.
Inclusion: 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: 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; Patients with distant metastasis (including nonregional lymph nodes metastasis) will be excluded; Pregnancy/Lactating women.