Phase II Randomized Non-Inferiority Trial of Hypofractionated Radiotherapy for Locally Advanced Cervical Cancer in Uganda
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.
• Females 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 (PS) of ≤ 2
• Absolute neutrophil count ≥ 1,500 cells/mm\^3 (1.5 x 10\^9/L)
• Platelets ≥ 100,000 cells/mm\^3 (100 x 10\^9/L)
• Hemoglobin ≥ 9.0 g/dL
• Leukocyte count ≥ 4,000 cells/mm\^3 (4.0 x 10\^9/L)
• Creatinine clearance \> 60 mL/mins, calculated 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 attributed to the use of antiretroviral therapy (ART)
• HIV-positive participants must be on a stable ART regimen for at least 6 weeks prior to enrollment