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CTRI Number  CTRI/2024/01/061609 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to evaluate the efficacy of radiation therapy in inoperable gall bladder cancer. 
Scientific Title of Study   Systemic therapy with or without radiation therapy in unresectable non metastatic gall bladder carcinoma open label parallel arm phase 2 phase 3 integrated randomized clinical trial (RUGB) 
Trial Acronym  RUGB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Department of radiation oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Department of radiation oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar Gudi 
Designation  Assistant Professor, Radiation Oncology 
Affiliation  Tata Memorial Centre 
Address  Department of radiation oncology, Tata Memorial Hospital, 10th floor, room no-1002, Dr Ernest Borges Marg Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224176863  
Fax    
Email  shivakumargudi@gmail.com  
 
Source of Monetary or Material Support  
Intramural funding, tata memorial hospitaldr ernest borges marg parel mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr Ernest Borges Marg Parel Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivakumar Gudi  Tata Memorial Hospital  Department of radiation oncology 10th floor, Room no 1002, Tata Memorial Hospital, Dr Ernest Borges Marg Parel
Mumbai
MAHARASHTRA 		 02224176863

shivakumargudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 10 sessions (up to 60Gy in 15 sessions) over 2-3 weeks - This is followed by systemic therapy as in the Systemic therapy arm 
Comparator Agent  Systemic Therapy  Participants will receive one of the following Gemcitabine-based systemic therapy alone 1 Gemcitabine plus cisplatin 2 Gemcitabine plus oxaliplatin 3 Gemcitabine plus cisplatin plus Durvalumab 4 Gemcitabine plus cisplatin plus nab-paclitaxel Duration- 3 months (in addition to 3 months previously received) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  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

 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Median overall survival
Time interval between the date of diagnosis and death due to any case. 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
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 4 		 1. 2 years
2. 2 years
3. 6 months
4. 3 years
5. 2 years 
 
Target Sample Size   Total Sample Size="249"
Sample Size from India="249" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 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.  
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