Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Radiotherapy and Systemic therapy: Participants will receive radiation therapy in addition to systemic therapy Hypofractionated external image guided radiation to a dose of 40-55Gy in 1
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median overall survival Time interval between the date of diagnosis and death due to any case.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of disease progression or death from any cause 2. Locoregional progression free survival Time interval between the date of diagnosis and radiological or histological (whichever earlier) evidence of locoregional disease progression or death from any cause 3. Response rate Response to treatment after completion of 6 months of systemic therapy with or without radiotherapy will be assessed using a PET CT or CECT scan using the RECIST (Ver 1.1) criteria 4. Acute and late toxicities RTOG and CTCAE v5 criteria 5. Quality of life assessment EORTC QLQ-c30 and FACT-Hep version 4Timepoint: 1. 2 years 2. 2 years 3. 6 months 4. 3 years 5. 2 years | — |
Countries
India
Contacts
Public ContactDr Shivakumar Gudi
Tata Memorial Centre
Outcome results
None listed