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RECRUITING
NCT07625943
NA

HYPOfractionated RadioTherapy in Cervical Cancer

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: Hypofractionated Radiotherapy in Cervical Cancer: A Non-inferiority Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

396

Start Date

2026-01-15

Completion Date

2030-01-30

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

RADIATION

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.

RADIATION

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.

Locations (1)

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

New Delhi, New Delhi, India