| CTRI Number |
CTRI/2025/09/095262 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aims to evaluate whether, in our setting, it is possible to administer two sessions of high-dose-rate (HDR) brachytherapy per week without significantly raising the incidence of acute toxicities compared to the standard regimen.
|
|
Scientific Title of Study
|
Comparison of toxicities and locoregional control between two high dose rate intracavitary brachytherapy regimens in the patients receiving curative treatment for carcinoma cervix: A Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 56(74)2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankita Prusty |
| Designation |
Junior resident |
| Affiliation |
IGMC SHIMLA |
| Address |
Dept of Radiotherapy, TCCC, IGMC SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8249091074 |
| Fax |
|
| Email |
1996prustyankita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Dr Sidharth Vats |
| Designation |
Professor |
| Affiliation |
IGMC SHIMLA |
| Address |
Dept of Radiotherapy, TCCC, IGMC SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
|
| Fax |
|
| Email |
drsiddharthvats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Prusty |
| Designation |
Junior resident |
| Affiliation |
IGMC SHIMLA |
| Address |
Room number 30, Dept of Radiotherapy, TCCC, IGMC SHIMLA
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
8249091074 |
| Fax |
|
| Email |
1996prustyankita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Radiotherapy, TCCC, IGMC , Shimla, HP, PIN-171001 |
|
|
Primary Sponsor
|
| Name |
Dept of Radiotherapy |
| Address |
TCCC IGMC |
| Type of Sponsor |
Government medical college |
|
|
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 Ankita Prusty |
Indira Gandhi Medical College |
Dept of Radiotherapy,TCCC, IGMC, SHIMLA
Shimla
HIMACHAL PRADESH |
8249091074
1996prustyankita@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Conventional Arm |
Receiving sessions of HDR ICB, one session per week. Interval between two sessions will remain one week.
|
| Comparator Agent |
Study Arm |
Receiving sessions of HDR ICB, two sessions per week. Interval between two sessions will remain 3-4 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
KPS a more than 70
Stage IB2 to IVA
Baseline blood investigation are within normal limit.
No previous treatment for the same.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare acute as well as late bowel and bladder toxicities between the 2 regimens. |
At first follow up which is at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare loco regional control between the two regimens |
At first follow up at 8 weeks, at second follow up at 16 weeks & at third follow up at 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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 3 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 objective of the study is to see if it is feasible to reduce the duration of curative treatment for carcinoma cervix without increasing the acute and late toxicity by adapting the newer regimen. |