A clinical trial to evaluate the efficacy of radiation therapy in inoperable gall bladder cancer.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1 Histologically proven biopsy or cytology adenocarcinoma of gall

bladder. Gall bladder neck primaries with hilar block mimicking hilar

cholangiocarcinoma will also be included

2 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

3 Locally advanced disease with one or more of the following

4 Extensive liver infiltration not amenable for surgery but feasible for safe

radiation delivery -Liver minus gross tumor volume at least 700cc

5 Vascular involvement encasement more than 180-degree angle of one of the

vessels Hepatic artery main portal vein right or left portal vein

6 Obstructive jaundice with hilar involvement (type 2 non communicating

block and higher blocks as per Bismuth-Corlette classification)

7 Stable disease or partial response-RECIST 1.1 after initial 3 months of

Gemcitabine based chemotherapy

8 Eastern Cooperative Oncology Group performance status of 0 1 or 2 fit for chemotherapy

9 Normal hematological and renal and hepatic functions allowing safe delivery of chemotherapy

Exclusion Criteria

1 Patients with distant metastasis including non regional lymph nodes metastasis will be excluded

2 Prior abdominal therapeutic radiation

3 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

4 Pregnancy or Lactating women

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median overall survival <br/ ><br>Time interval between the date of diagnosis and death due to any case.Timepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
1. Progression free survival <br/ ><br>Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of disease <br/ ><br>progression or death from any cause <br/ ><br> <br/ ><br>2. Locoregional progression free survival <br/ ><br>Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of locoregional <br/ ><br>disease progression or death from any cause <br/ ><br> <br/ ><br>3. Response rate <br/ ><br>Response to treatment after completion of 6 months of systemic therapy with or without radiotherapy will be assessed <br/ ><br>using a PET CT or CECT scan using the RECIST (Ver 1.1) criteria <br/ ><br> <br/ ><br>4. Acute and late toxicities <br/ ><br>RTOG and CTCAE v5 criteria <br/ ><br> <br/ ><br>5. Quality of life assessment <br/ ><br>EORTC QLQ-c30 and FACT-Hep version 4Timepoint: 1. 2 years <br/ ><br>2. 2 years <br/ ><br>3. 6 months <br/ ><br>4. 3 years <br/ ><br>5. 2 years