| CTRI Number |
CTRI/2026/02/102928 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Guidelines for radiation dose reporting in rectal cancer |
|
Scientific Title of Study
|
GI GEC rectal brachy dose reporting project |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
Tata Memorial |
| Address |
Room No. 1125,HBB,Department of Radiation Oncology , Tata Memorial Centre, Parel Mumbai , Maharashtra, 400012 , India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
Tata Memorial |
| Address |
Room No. 1125,HBB,Department of Radiation Oncology , Tata Memorial Centre, Parel Mumbai , Maharashtra, 400012 , India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Krishnatry |
| Designation |
Professor |
| Affiliation |
Tata Memorial |
| Address |
Room No. 1125,HBB,Department of Radiation Oncology , Tata Memorial Centre, Parel Mumbai , Maharashtra, 400012 , India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177028 |
| Fax |
|
| Email |
krishnatry@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre, parel,Mumbai,Maharashtra India pin 400012 |
|
|
Primary Sponsor
|
| Name |
Maastricht Radiation Oncology Maastro Clinic |
| Address |
Dr. Tanslaan 12, Maastricht, The Netherlands. Pin:6229ET |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rahul Krishnatry |
Tata Memorial Centre |
Room 1125, Department of Radiation Oncology , TMH , Parel , Mumbai , Maharshtra, India 400012
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
02224177028
krishnatry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-I, Tata Memorial Centre, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Rectal cancer patients who have been treated with rectal high dose rate brachytherapy at participating centers.
Availability of complete treatment planning data including dose volume histogram information.
Treatment plans generated using clinically approved treatment planning systems.
Cases where target and relevant structures are delineated according to the specified delineation guideline or can be updated accordingly. |
|
| ExclusionCriteria |
| Details |
Cases with incomplete or missing treatment planning or dose volume histogram data.
Treatment plans not suitable for dose volume histogram analysis due to technical limitations.
Cases where required delineation structures are unavailable and cannot be reconstructed or updated. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identification of robust dose volume and depth dose metrics for rectal high dose rate brachytherapy that are sensitive to clinically relevant variations in dose distribution and remain stable across contouring variability and treatment planning system differences |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate inter-centre variability in contemporary clinical practice; assess the sensitivity of dosimetric outcomes to unavoidable target delineation uncertainties; examine susceptibility to variations in DVH calculation methods, treatment planning system software, & minor source positional deviations; & determine the feasibility of categorizing robust dosimetric metrics into entry-level, advanced-level, & research-level dose reporting frameworks |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to identify robust dose volume and depth dose metrics for dose reporting in rectal high dose rate brachytherapy. The primary purpose of the protocol is to evaluate dosimetric parameters that are sensitive to clinically relevant variations in dose distribution while remaining stable against unavoidable delineation uncertainties, contouring variability, and differences between treatment planning systems.
The study will collect and analyze dose volume histogram based parameters from rectal brachytherapy treatment plans generated at multiple centers using different applicators and planning systems. Candidate metrics will be assessed for their ability to reflect differences between treatment plans and patients, as well as their robustness to contouring variation and dose calculation differences.
The underlying hypothesis of the study is that a limited set of dose volume metrics can be identified that consistently represent dose distribution characteristics in rectal high dose rate brachytherapy and can be reliably recorded and reported across centers. The findings of this study are expected to support the development of standardized dose reporting guidelines and facilitate improved consistency in clinical practice and future research. |