| CTRI Number |
CTRI/2025/08/092387 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to find if high dose of radiotherapy in cervix cancer be completed in less time and its effects. |
|
Scientific Title of Study
|
Hypo fractionated radiotherapy in carcinoma cervix- A phase II study. |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyesh Kumar |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherapy and Oncology
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087441314 |
| Fax |
|
| Email |
divyeshanand1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divyesh Kumar |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherapy and Oncology
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087441314 |
| Fax |
|
| Email |
divyeshanand1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divyesh Kumar |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Radiotherpy and Oncology
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087441314 |
| Fax |
|
| Email |
divyeshanand1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Non Funded, Post graduate Institute of Medical Education and Research,Sector-12,Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Institute Ethics Committee,Post Graduate Institute of Medical Education and Research,sector 12, Chandigarh,160012. |
| Type of Sponsor |
Other [Nonfunded] |
|
|
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 |
| DrDivyesh kumar |
Post Graduate Institute of Medical Education and Research |
Department of Radiotherapy and Oncology,Roon mon.20 Nehru Extension,Post Graduate Institute of Medical Education and Research,Sector 12,India.160012
Chandigarh
CHANDIGARH |
7087441314
divyeshanand1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, (2) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hypofractionated Radiation Thearpy |
External beam radiation therapy of 42.6 Gy in 15 fractionation in 3 weeks followed by intracavitary Brachytherapy of 7 Gy x 3 fractions i,e weekly for 3 weeks will be given. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Biopsy proven cancer cervix.
Clinical Stage upto IIB with or without radiological IIIC1
KPS more than 70.
Willing for participate.
|
|
| ExclusionCriteria |
| Details |
Post op patients.
Pregnant or lactating women.
Metastasis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess response and acute toxicities, if any |
assess response at 3 months and acute toxicities during Radiation therapy and uptil 6 months on 3 monthly follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| late toxicities, quality of life (QOL), Progression free survival (PFS) and overall survival (OS) |
at 6 months and 1 year. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/09/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
Hypofractionated radiotherapy (HFRT) is a treatment approach that shortens the overall duration of a radiotherapy treatment course by delivering fewer treatments but with a higher dose of radiation per daily treatment.The benefits of adopting hypofractionated radiotherapy regimens in low middle income countries (LMICs) has been less sought in the literature. Although feasibility studies in this regard are now being done in western countries, prospective studies in Indian setup are lacking. |