HYPOfractionated RadioTherapy in Cervical Cancer

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

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.

Conditions3

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