| CTRI Number |
CTRI/2026/01/101615 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Short-Course Radiation in Cervical Cancer Trial |
|
Scientific Title of Study
|
Hypofractionated Radiotherapy in Cervical Cancer: A Non-inferiority Randomized Controlled Trial |
| 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 KARUN KAMBOJ |
| Designation |
Assistant Professor -Radiation Oncology (NCI) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar
Jhajjar
HARYANA
122017
India |
| Phone |
9416613389 |
| Fax |
|
| Email |
karunkamboj04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KARUN KAMBOJ |
| Designation |
Assistant Professor -Radiation Oncology (NCI) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar
HARYANA
122017
India |
| Phone |
9416613389 |
| Fax |
|
| Email |
karunkamboj04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KARUN KAMBOJ |
| Designation |
Assistant Professor -Radiation Oncology (NCI) |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no. 104, Ist Division, Department of Radiation Oncology, National Cancer Institute, AIIMS , Jhajjar
HARYANA
122017
India |
| Phone |
9416613389 |
| Fax |
|
| Email |
karunkamboj04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varian Medical Systems, 3100 Hansen Way, Palo Alto, California, PIN CODE-94304-1030, United States of America |
|
|
Primary Sponsor
|
| Name |
Varian Medical Systems |
| Address |
Varian Medical Systems, Inc
3100 Hansen Way
Palo Alto, CA 94304, United States of America
|
| Type of Sponsor |
Other [ Corporate medical device company] |
|
|
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 KARUN KAMBOJ |
National Cancer Institute, AIIMS, Jhajjar |
Clinical Assessment Room, Department of Radiation Oncology, Basement Division, OPD Block, National Cancer Institute, All India Institute of Medical Sciences (AIIMS), Jhajjar, HARYANA
Jhajjar
HARYANA |
9416613389
karunkamboj04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
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 |
| Comparator Agent |
Arm I Standard arm |
Radiation Therapy 45 Gy in 25 fractions over 5 weeks with weekly cisplatin 40 mg 5 cycles with nodal boost to 55 Gy using simultaneous integrated boost followed by image guided HDR brachytherapy 7 Gy in 4 fractions.
The overall treatment time is 8 weeks in the standard arm. |
| Intervention |
Arm II Experimental arm |
Radiation Therapy 37.5 Gy in 15 fractions over 3 weeks with weekly cisplatin 40 mg 3 cycles, with nodal boost to 48 Gy using simultaneous integrated boost followed by image guided HDR brachytherapy 7 Gy in 4 fractions. The overall treatment time is 6 weeks in the intervention arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged 18 years or older with locally advanced cervical cancer suitable for primary treatment with chemoradiotherapy.
Pathologically confirmed carcinoma cervix squamous,adenocarcinoma,adeno-squamous carcinoma histology.
Patients with stage stage IB3 to IIIB and IIIC1, who have not undergone previous pelvic radiation therapy or surgery and have an Eastern Cooperative Oncology Group performance status of 0-2.
Signed informed consent.
Adequate end organ function hepatic, renal, cardiac reserve |
|
| ExclusionCriteria |
| Details |
Patients with stage IIIC2, IVA, or IVB
Patients with prior malignancies or active autoimmune diseases will be excluded from the study.
Other histology melanoma, small cell, basal cell carcinoma
Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment.
Contraindications to CEMRI, brachytherapy
Age less than 18 years.
Uncontrolled medical comorbidity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Locoregional recurrences |
At 3 months after completion, every 6 months till 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Acute toxicity |
Weekly during chemoradiation, and at completion and 3 months post radiotherapy |
| Late toxicity |
Graded using RTOG and EORTC criteria, collected from 3 months after completion of radiotherapy until end of 2 years post chemoradiation |
|
|
Target Sample Size
|
Total Sample Size="396"
Sample Size from India="396"
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)
|
01/03/2026 |
| 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="4"
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
|
This is a prospective non inferiority randomized controlled trial in locally advanced carcinoma cervix stages IB3 to IIIC1 comparing standard fractionated chemoradiation with a hypofractionated chemoradiation regimen. Patients are randomized by computer generated block randomization into two arms of 198 each to receive either IMRT 45 Gy in 25 fractions over 5 weeks with weekly cisplatin and nodal SIB boost to 55 Gy followed by image guided HDR brachytherapy, or IMRT 37.5 Gy in 15 fractions over 3 weeks with weekly cisplatin and nodal boost to 48 Gy followed by the same brachytherapy schedule. The primary outcome is pelvic loco regional recurrence at 3 months post treatment, and secondary outcomes include acute and late toxicities.
|