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Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda
Sponsor: Uganda Cancer Institute
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.
Official title: Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
278
Start Date
2026-03-11
Completion Date
2029-01-02
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Hypofractionated 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).
Conventional Fractionated Radiotherapy
Undergoing CFRT
Cisplatin
Undergoing Cisplatin
High-Dose Rate Brachytherapy
Undergoing HDR Brachytherapy
External Beam Radiotherapy Boost
Undergoing external beam radiotherapy boost
Computed Tomography
Undergoing CT scan
Biospecimen Collection
Undergoing blood sample collection
Questionnaire and Physical Exam
Ancillary Studies
Locations (1)
Uganda Cancer Institute
Kampala, Kampala, Uganda