Cervical cancer is among the most common gynecologic malignancies encountered in Low and Middle Income Countries. Tanzania, and the whole East African region where it belongs, has cervical cancer as the first malignancy in women, in both incidence and mortality. Despite the advances in management of cervical carcinoma, most of the Low-Income Countries lag in terms of treatment planning and delivery, considering the loads of patients that consult on a regular basis. Locally advanced cervical cancer status, as defined by the International Federation of Gynecology and Obstetrics confers to the patient a high recurrence and low survival rate risks altogether. Survival rates have been shown to have a decreasing tendency as the cancer stage increase. According to FIGO classification, the management of a locally advanced cervical cancer consists of a course of combined radiotherapy and chemotherapy, with a few added weeks of brachytherapy. As it has been shown before, both exposure and toxicity to any of the available treatment options could be lowered if some factors are taken into consideration. Encouraging results have been shown elsewhere. This study compares two different dose fractionations of High dose rate brachytherapy for selected cases of cervical carcinoma, and seeks to prove feasibility of both.
The study is an open-label, single institution, non-inferiority, phase 3 randomized controlled trial. Patients will be assigned (1:1), with a consecutive recruitment according to set randomization criteria, to receive two brachytherapy insertions of 8.5 Grays, one week apart (intervention group – A) or three brachytherapy insertions of 6.7 Grays, one week apart (control group – B). Patients will be enrolled then randomized to either group after satisfactory completion of a 5 week-course of both external beam radiotherapy, total dose of 50 Grays, on a 2 Gray daily in 25 fractions, combined with a weekly single agent cisplatin for a dose of 40 mg/m2. The study will have a recruitment phase spanning between April to June 2017 and a follow up phase from May 2017 to May 2018.
Clinical trial identification
Legal entity responsible for the study
Muhimbili University of Health and Allied Sciences
All authors have declared no conflicts of interest.