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

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.

Conditions

• Cervical Cancer
• Cervix Cancer
• Cervical Adenocarcinoma
• Cervical Small Cell Carcinoma
• Cervical Adenosquamous Carcinoma

Interventions

RADIATION

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).

RADIATION

Conventional Fractionated Radiotherapy

Undergoing CFRT

DRUG

Cisplatin

Undergoing Cisplatin

RADIATION

High-Dose Rate Brachytherapy

Undergoing HDR Brachytherapy

RADIATION

External Beam Radiotherapy Boost

Undergoing external beam radiotherapy boost

PROCEDURE

Computed Tomography

Undergoing CT scan

PROCEDURE

Biospecimen Collection

Undergoing blood sample collection

OTHER

Questionnaire and Physical Exam

Ancillary Studies

Sponsors & Collaborators

• Varian Medical Systems

  collaborator INDUSTRY

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• Uganda Cancer Institute

  lead OTHER

Principal Investigators

• Solomon Kibudde, MBChB, MMed. · Uganda Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-11

Primary Completion

2028-01-02

Completion

2029-01-02

Countries

• Uganda

Study Locations