Postoperative hypofractionated intensity-modulated radiation therapy in cervical cancer: prospective phase 2 trial (POHIM_RT study)

Objective: This study evaluates the safety and efficacy of hypofractionated intensity-modulated radiation therapy (IMRT) following radical hysterectomy. Methods: This phase II, non-randomized multicenter trial included 61 patients with cervical cancer who were eligible for adjuvant RT after radical hysterectomy. Participants received 40 Gy in 16 fractions using IMRT to whole pelvis. The primary endpoint was the incidence of grade 3 or higher acute gastrointestinal, genitourinary, and hematologic toxicities. Secondary endpoints included patient-reported quality of life and disease-free survival (DFS). Acute toxicities were monitored using the National Cancer Institute's Common Terminology Criteria for Adverse Events v4.0. Results: Among the participants, the incidence of grade 3 or higher acute toxicities was 1.6 % (90 % confidence interval, 0–3.7 %). After a median follow-up of 39.5 months, the 3-year DFS rate was 87.1 %, and no grade ≥ 3 late toxicities were reported during the follow-up period. Conclusion: Hypofractionated IMRT post-radical hysterectomy demonstrated low severe toxicity rates and effective disease control, suggesting a feasible alternative to conventional fractionation. However, further randomized comparative trials are required to validate the results of this study. Trial Registration: Registered on ClinicalTrials.gov, NCT03239626.