Publication:

Postoperative hypofractionated radiation in cervical and endometrial tumours: phase II study protocol for a prospective phase II non-randomised trial

Background For women with endometrial or cervical cancer treated surgically, presence of adverse histopathological features is associated with increased risk of recurrence. While conventional post-op radiotherapy uses standard fractionation to treat these patients, use of hypofractionation is understudied. Study aims to evaluate long-term safety of hypofractionated post-op pelvic radiotherapy in patients with cervical and endometrial cancers. Primary objectives were to assess 3-year cumulative incidence of late grade ≥2 GI or genitourinary toxicity in patients with cervical or endometrial cancer requiring adjuvant (chemo) radiation treated with hypofractionated radiotherapy.

Methods Single-arm prospective study wherein patients will receive adjuvant RT to a dose of 39 Gy in 13 fractions, with or without concurrent weekly cisplatin. Vaginal brachytherapy (2 fractions of 6 Gy HDR) will follow EBRT based on indication. Patients will be followed at regular intervals for assessment of toxicity (graded using CTCAE v5.0), pelvic control, and QoL (using EORTC QLQ-C30 and CX24/EN24). Age≥18 years; ECOG performance status ≤2; post-op carcinoma of cervix/endometrium requiring adjuvant radiotherapy with/without concurrent chemotherapy were included. Macroscopic residual disease post-operatively; requirement for extended field radiotherapy; prior chemotherapy for any malignancy and previous pelvic radiotherapy were excluded. Primary endpoint was 3-year cumulative incidence of late grade ≥2 gastrointestinal or genitourinary toxicity, as assessed by CTCAE version 5.0. Sample size was 90.

Conclusions Recruitment is estimated to be completed by 2027 and results may be published by 2028 after adequate follow up.