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

Sponsor
Uganda Cancer Institute
Study ID
NCT07276360
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated Radiation Therapy — RADIATION
    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 — RADIATION
    Undergoing CFRT
  • Cisplatin — DRUG
    Undergoing Cisplatin
  • High-Dose Rate Brachytherapy — RADIATION
    Undergoing HDR Brachytherapy
  • External Beam Radiotherapy Boost — RADIATION
    Undergoing external beam radiotherapy boost
  • Computed Tomography — PROCEDURE
    Undergoing CT scan
  • Biospecimen Collection — PROCEDURE
    Undergoing blood sample collection
  • Questionnaire and Physical Exam — OTHER
    Ancillary Studies

Study Details

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.

Key Dates

First listed
Dec 11, 2025
Start date
Mar 11, 2026
Status verified
Mar 2026
Primary completion
Jan 2, 2028
Completion
Jan 2, 2029

Study Design

Enrollment
278 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (HFRT)
    Patients undergo HFRT QD, Monday-Friday, for 5 fractions weekly for 16 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.
  • Active Comparator: Arm II (CFRT)
    Patients undergo CFRT QD, Monday-Friday, for 5 fractions weekly for up to 25 fractions in the absence of disease progression or unacceptable toxicity. Starting on day 1 of radiation therapy, patients receive cisplatin infusion over 1 hour QW during radiation therapy. Starting by week 4, patients may also undergo HDR brachytherapy twice weekly for a total of 4 doses. Patients ineligible for brachytherapy undergo a sequential external beam boost. Additionally, patients undergo CT and blood sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 90 days post-treatment ]

Central Contacts

Find similar trials

Nationwide
Cervical cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials

Related Studies