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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
National Cancer Institute, All India Institute of Medical Sciences, New Delhi, India
RECRUITING
New Delhi
Contact Information
Primary
Karun Kamboj, MD - Radiation Oncology
karunkamboj04@aiims.edu
9416613389
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2030-01-30
Participants
Target number of participants: 396
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences
Collaborators: Varian, a Siemens Healthineers Company

This content was sourced from clinicaltrials.gov