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Hypofractionated Versus Standard Chemoradiotherapy in the Definitive Treatment of Uterine Cervix Cancer: Interim Results of a Randomized Controlled Clinical Trial Publisher Pubmed



Maddah Safaei A1 ; Esmati E1 ; Gomar M1 ; Akhavan S2 ; Sheikh Hasani S3 ; Malekzadeh Moghani M4 ; Zamani N3 ; Moshtaghi M5 ; Malek M6 ; Jafari F1 ; Sharifian A1 ; Kolahdouzan K1
Authors
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Authors Affiliations
  1. 1. Radiation Oncology Research Center (RORC), Cancer Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Department of Obstetrics and Gynecology, Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Department of Oncologic Gynecology, Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Radiation Oncology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5. Radiation Oncology Department, Booali Hospital, Tehran, Iran
  6. 6. Advanced Diagnostic and Interventional Radiology Research Center (ADIR), Radiology Department, Imam Khomeini Hospital Complex (IKHC), Tehran University of Medical Sciences, Tehran, Iran

Source: Journal of Cancer Research and Clinical Oncology Published:2025


Abstract

Purpose: Concurrent chemoradiation has been the mainstay of treatment for cervix cancer. We aimed to evaluate the non-inferiority of hypofractionated chemoradiation. Methods: This study was designed as a phase 2, 1:1 randomized, investigator-blinded, controlled, non-inferiority trial and we report the interim results after 50% accrual. Cervical cancer patients with FIGO stages IIA–IIIC were recruited from April 2021 to September 2022. The intervention consisted of 40 Gy of 3D-conformal radiation therapy (RT) in 15 fractions over 3 weeks. In the control group, patients received standard chemoradiation of 45 Gy in 25 fractions over 5 weeks. Both groups received concurrent weekly cisplatin (40 mg/m2). Intravaginal brachytherapy of 28 Gy in 4 weekly fractions was delivered starting 1 week after the end of chemoradiation. The primary outcome was complete clinical response(CCR) at 3 months. Secondary outcomes included acute gastrointestinal (GI), genitourinary(GU), skin, and hematologic toxicities. A p value less than 0.05 was considered significant for analyses. Results: 59 patients were randomized; 30 in the control group and 29 in the intervention group. 20/30 (66.7%) of the patients in the control group and 19/29 (65.5%) in the intervention group achieved a CCR (absolute difference of 0.011, 95% CI − 0.23 to 0.25, p value: 0.13). There was a significantly higher rate of acute grade ≥ 3 GI toxicity in the intervention group (27.6%) compared with the control group (6.7%) (p value 0.032). Conclusions: Despite an absolute difference of 1.1% in the 3-month CCR, our interim analysis failed to show the non-inferiority of the hypofractionated chemoradiation. Due to the higher GI toxicities, we will continue this trial using intensity-modulated radiation therapy. Registration number and date: ClinicalTrials.gov: NCT04831437, 2021.4.1. © 2024, The Author(s).