Actively Recruiting
Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda
Led by Uganda Cancer Institute · Updated on 2026-03-27
278
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
U
Uganda Cancer Institute
Lead Sponsor
V
Varian Medical Systems
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix without prior treatment
- Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3, IIA, IIB, IIIA, IIIB, or IIIC
- Able to provide written informed consent in English, Luganda, Runyankole, or Lango
- Willing to attend post-treatment follow-up for up to 12 months
- Fit for concurrent chemotherapy with cisplatin
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 2
- Absolute neutrophil count 2 1,500 cells/mmB3 (1.5 x 10B9/L)
- Platelets 2 100,000 cells/mmB3 (100 x 10B9/L)
- Hemoglobin 2 9.0 g/dL
- Leukocyte count 2 4,000 cells/mmB3 (4.0 x 10B9/L)
- Creatinine clearance > 60 mL/min using the Cockcroft-gault equation for women
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the upper limit of normal (ULN)
- Total bilirubin < 2 x ULN unless due to antiretroviral therapy
- HIV-positive participants must be on stable antiretroviral therapy for at least 6 weeks prior to enrollment
You will not qualify if you...
- Prior hysterectomy (total or subtotal)
- Evidence of distant metastases
- Prior pelvic or abdominal radiotherapy
- Presence of bilateral hip prosthesis interfering with radiotherapy
- History of inflammatory bowel disease or other conditions complicating radiotherapy
- Pregnancy at time of enrollment
- Concurrent untreated invasive malignancy
- Uncontrolled medical or psychiatric conditions limiting study compliance
- Uncontrolled HIV infection with viral load > 2,000 copies/mL
- CD4 count less than 200 cells/mmB3
AI-Screening
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Trial Site Locations
Total: 1 location
1
Uganda Cancer Institute
Kampala, Kampala, Uganda, 256
Actively Recruiting
Research Team
S
Solomon Kibudde, MBChB, MMed.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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