RecruitingPhase 2NCT07276360

Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda

Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda


Sponsor

Uganda Cancer Institute

Enrollment

278 participants

Start Date

Mar 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial compares the effect of hypofractionated radiotherapy (HFRT) to conventional fractionated radiotherapy (CFRT) when given in combination with cisplatin and brachytherapy in patients with stage IB3, II, or III cervical cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. CFRT delivers the total dose of radiation over the amount of time according to standard practice. HFRT delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. HFRT shortens treatment duration and may reduce costs and may improve the completion rates. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HFRT may be safe, tolerable, and/or as effective as CFRT when given in combination with cisplatin and brachytherapy in treating patients with stage IB3, II or III cervical cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a drug called Cisplatin, and others for people with cervical adenocarcinoma, cervical adenosquamous carcinoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypofractionated Radiation Therapy

Undergoing HFRT - The prescription dose will be 40 Gy in 16 fractions (2.5 Gy/fraction) to the entire pelvis, with concurrent integrated nodal boost at 3.0 Gy per fraction (48 Gy) to involved (positive) pelvic nodes, delivered once a day, Monday through Friday, 5 fractions per week, using volumetric modulated arc therapy (VMAT).

RADIATIONConventional Fractionated Radiotherapy

Undergoing CFRT

DRUGCisplatin

Undergoing Cisplatin

RADIATIONHigh-Dose Rate Brachytherapy

Undergoing HDR Brachytherapy

RADIATIONExternal Beam Radiotherapy Boost

Undergoing external beam radiotherapy boost

PROCEDUREComputed Tomography

Undergoing CT scan

PROCEDUREBiospecimen Collection

Undergoing blood sample collection

OTHERQuestionnaire and Physical Exam

Ancillary Studies


Locations(1)

Uganda Cancer Institute

Kampala, Kampala, Uganda

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NCT07276360


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