Postoperative hypofractionated radiation in cervical and endometrial tumours: phase II study protocol for a prospective phase II non-randomised trial
DOI:
https://doi.org/10.18203/2349-3259.ijct20261389Keywords:
Hypofractionated radiotherapy, Cervical cancer, Endometrial cancer, Postop radiotherapy, Phase II trial, Toxicity, QoLAbstract
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.
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