Radiation Therapy in Unresectable Gall Bladder Cancer

Launched by TATA MEMORIAL CENTRE · Jan 10, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well radiation therapy works when combined with chemotherapy or immunotherapy for patients with inoperable gallbladder cancer. The main goal is to see if adding radiation helps patients live longer and improves their quality of life compared to those who only receive systemic therapy. Participants will be randomly assigned to one of two treatment groups, and researchers will compare how well each group does.

To be eligible for this study, participants need to be at least 18 years old and have a confirmed diagnosis of gallbladder cancer that hasn't spread to other parts of the body. They should have locally advanced cancer that is not suitable for surgery but can safely receive radiation treatment. Additionally, participants must have stable health and normal blood and organ function to tolerate chemotherapy. It’s important to know that patients with previous abdominal radiation or other active cancers won't be included. Those who join the trial can expect regular check-ups and monitoring as part of their treatment.

Gender

ALL

Eligibility 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