🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT07625943
Recruiting Not applicable

HYPOfractionated RadioTherapy in Cervical Cancer

NCT07625943 · tracked via the Priya Life Science India tracker
Sponsor
All India Institute of Medical Sciences
Phase
Not applicable
Started
2026-01-15
Last updated
2026-06-16

Condition(s) studied

Cervical Cancer Squamous CellCervical Cancer

Investigational drug(s) / intervention(s)

Hypofractionated ChemoradiationStandard fractionated chemoradiation

Hypofractionated Chemoradiation: Hypofractionated chemoradiation consisting of external beam radiotherapy to 37.5 Gy in 15 fractions over approximately 3 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Standard fractionated chemoradiation: Standard fractionated chemoradiation consisting of external beam radiotherapy to 45 Gy in 25 fractions delivered in conventional daily fractions over 5 weeks, concurrent weekly cisplatin, and brachytherapy to 700 cGy in 4 fractions.

Study summary

The study is a prospective, randomized, non-inferiority clinical trial which will test whether a short course of radiation treatment (hypofractionation) for cervical cancer works as well as the standard longer course. Cervical cancer is one of the most common cancers in women in India, and many patients have trouble completing treatment because it takes several weeks and requires many hospital visits.

In this trial, females with locally advanced cervical cancer will be randomly assigned to one of two treatment groups. One group will receive the standard radiation schedule with External Beam RadioTherapy (EBRT) over about 5 weeks, weekly cisplatin chemotherapy, and brachytherapy. The other group will receive a shorter, hypofractionated external beam radiotherapy schedule over about 3 weeks, the same chemotherapy, and brachytherapy.

Researchers will compare the two groups to see whether the hypofractionated schedule is non-inferior to the standard radiation therapy schedule. The main outcomes will be tumor control in the pelvis, side effects, survival, and quality of life. If the hypofractionated schedule meets the non-inferiority limit, it could reduce treatment time, improve patient convenience, and help more people receive treatment in busy cancer centers in emerging countries.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: Female participants aged 18 to 65 years. Histopathologically confirmed cervical cancer. FIGO stage IB3 to IIIC1. Suitable for definitive concurrent chemoradiation. ECOG performance status 0 to 2. Adequate hematological, renal, and hepatic function. Able and willing to provide informed consent. Exclusion Criteria: ECOG performance status 3 or higher. FIGO stage IIIC2, IVA, or IVB. Prior pelvic radiotherapy or prior chemotherapy for cervical cancer. Inflammatory bowel disease. Hydronephrosis. Pregnancy. Synchronous malignancy. Any serious medical condition that would interfere with protocol treatment or follow-up.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India New Delhi New Delhi Recruiting

More All India Institute of Medical Sciences trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625943 on ClinicalTrials.gov ↗ ← All trials in India