Status:
RECRUITING
Radiation Therapy in Unresectable Gall Bladder Cancer
Lead Sponsor:
Tata Memorial Centre
Conditions:
Gall Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 inop...
Detailed Description
Gallbladder cancer (GBC) incidence is exceptionally high in India and most patients present with an unresectable or advanced disease. There is limited clinical evidence on optimal therapy of biliary t...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 21 2029
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT06214572
Start Date
March 7 2024
End Date
July 21 2029
Last Update
April 11 2025
Active Locations (1)
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1
Tata Memorial Centre
Mumbai, Maharashtra, India, 400012