| CTRI Number |
CTRI/2025/08/093569 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of high dose targeted radiation therapy in Gall bladder cancer. |
|
Scientific Title of Study
|
EVALUATION OF SAFETY AND EFFICACY OF STEREOTACTIC BODY RADIOTHERAPY IN
UNRESECTABLE GALL BLADDER CANCER: A PROSPECTIVE COHORT STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Manisha Kumari |
| Designation |
Junior Resident |
| Affiliation |
Department of Radiation Oncology. All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Radiation Oncology. All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9805709154 |
| Fax |
|
| Email |
manishathakur09er@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deepak Kumar Das |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Radiation Oncology. All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7978760783 |
| Fax |
|
| Email |
radonc_deepak@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Deepak Kumar Das |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Radiation Oncology. All India Institute of Medical Sciences, Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7978760783 |
| Fax |
|
| Email |
radonc_deepak@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar
Khordha, Odisha-751019, India |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Kumari |
| Address |
All India Institute of Medical Sciences, Bhubaneswar
Khordha, Odisha-751019, India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manisha Kumari |
All India Institute of Medical Sciences Bhubaneswar |
Department of Radiation Oncology. All India Institute of Medical Sciences Bhubaneswar
Khordha 751019 Odisha India
Khordha
ORISSA |
9805709154
manishathakur09er@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE For Faculty Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of efficacy and safety of stereotactic body radiotherapy-Prospective cohort study single arm
in unresectable gall bladder cancer by volumetric arc therapy (VMAT) technique at a dose
of 30Gray in 5 fractions |
All the patients will receive 4 cycles of neo-adjuvant
chemotherapy with Gemcitabine (1gm/m2) (IV) (Day 1 and Day
8) and Cisplatin (25 mg/m2) (Day 1 and Day 8), every 3 weeks.
Response will be assessed after 4 weeks of last chemotherapy. If
there is partial response or stable disease according to response
evaluation criteria in solid tumours (RECIST )1.1 criteria,
patients will be planned for stereotactic body radiotherapy
(SBRT) by volumetric arc therapy (VMAT) technique at a dose
of 30Gray in 5 fractions, followed by response assessment after
6 weeks. Response assessment will be done by triple phase CECT
abdomen/CEMRI abdomen. Depending on the response, further
treatment will be given as per departmental protocol.Depending on the response, further
treatment will be given as per departmental protocol. Patients will
be followed up every 3 monthly for the first 2 years with serum
CEA and CA 19.9. Triple phase CECT abdomen will done every
6 months or if there is clinical or biochemical disease
progression. |
| Comparator Agent |
NIL |
NO COMPARISON GROUP |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ECOG PS 0-2 histologically proven unresectable non metastatic gallbladder cancer |
|
| ExclusionCriteria |
| Details |
Patients with distant metastasis at presentation
Prior radiotherapy, Pregnant patients. Bilirubin more than 5mg/Dl.Liver enzymes three times or more above the upper limit of normal. one or more than one comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Response assessment following SBRT as per RECIST 1.1 criteria |
6 weeks after completion of SBRT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acute Gastrointestinal toxicity as per RTOG criteria |
During treatment & till 6 weeks following SBRT |
| To assess resectability following SBRT |
After 6 weeks of SBRT |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
14/09/2026 |
| 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="1"
Months="9"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By contacting the principal investigator via email.
- For how long will this data be available start date provided 05-01-2028 and end date provided 05-01-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Gallbladder cancer is the most common biliary tract malignancy and the fifth leading gastrointestinal cancer worldwide.The overall response rate with chemotherapy and radiotherapy alone are 38.4 and 26 respectively Chemotherapy gemcitabine plus cisplatin is the standard treatment for unresectable advanced GBC, though outcomes remain poor. The role of chemoradiotherapy following chemotherapy is still unclear The major limitation of conventional external beam radiotherapy is the sensitivity of the liver and adjacent gastrointestinal structures. In contrast, SBRT offers a highly precise, safe, and effective option for treating hepatobiliary and pancreatic cancers Additionally, SBRT delivers higher biological effective doses of radiation in fewer sessions, typically completing treatment in 1 to 5 sessions, compared to the several weeks required for CRT This shorter treatment duration is especially advantageous for patients with poor general health or advanced cancers The fewer day of radiation with SBRT offers fewer days off of systemic therapy |