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Study protocol for prospective multi-institutional phase III trial of standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC)

 Yong Bae Kim  ;  Hwa Kyung Byun  ;  Chan Woo Wee  ;  Hojin Kim  ;  Seyoung Kim  ;  Gowoon Yang  ;  Jina Kim  ;  Sang Joon Park  ;  Jung-Yun Lee 
 BMC CANCER, Vol.23(1) : 1014, 2023-10 
Journal Title
Issue Date
Aged ; Carcinoma, Ovarian Epithelial / radiotherapy ; Clinical Trials, Phase III as Topic ; Female ; Humans ; Multicenter Studies as Topic ; Neoplasm Recurrence, Local / etiology ; Neoplasm Recurrence, Local / radiotherapy ; Ovarian Neoplasms* / etiology ; Ovarian Neoplasms* / radiotherapy ; Prospective Studies ; Radiosurgery* / methods ; Randomized Controlled Trials as Topic ; Standard of Care
Overall survival ; Recurrent ovarian cancer ; SABR
Background: Efforts have been made to investigate the role of salvage radiotherapy (RT) in treating recurrent ovarian cancer (ROC). Stereotactic ablative radiation therapy (SABR) is a state-of-the-art therapy that uses intensity modulation to increase the fractional dose, decrease the number of fractions, and target tumors with high precision.

Methods: The SABR-ROC trial is a phase 3, multicenter, randomized, prospective study to evaluate whether the addition of SABR to the standard of care significantly improves the 3-year overall survival (OS) of patients with ROC. Patients who have completed the standard treatment for primary epithelial ovarian cancer are eligible. In addition, patients with number of metastases ≤ 10 and maximum diameter of each metastatic site of gross tumor ≤ 5 cm are allowed. Randomization will be stratified by (1) No. of the following clinical factors met, platinum sensitivity, absence of ascites, normal level of CA125, and ECOG performance status of 0-1; 0-3 vs. 4; (2) site of recurrence; with vs. without lymph nodes; and (3) PARP inhibitor; use vs. non-use. The target number of patients to be enrolled in this study is 270. Participants will be randomized in a 1:2 ratio. Participants in Arm 2 will receive SABR for recurrent lesions clearly identified in imaging tests as well as the standard of care (Arm 1) based on treatment guidelines and decisions made in multidisciplinary discussions. The RT fraction number can range from 1 to 10, and the accepted dose range is 16-45 Gy. The RT Quality Assurance (QA) program consists of a three-tiered system: general credentialing, trial-specific credentialing, and individual case reviews.

Discussion: SABR appears to be preferable as it does not interfere with the schedule of systemic treatment by minimizing the elapsed days of RT. The synergistic effect between systemic treatment and SABR is expected to reduce the tumor burden by eradicating gross tumors identified through imaging with SABR and controlling microscopic cancer with systemic treatment. It might also be beneficial for quality-of-life preservation in older adults or heavily treated patients.
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1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yong Bae(김용배) ORCID logo https://orcid.org/0000-0001-7573-6862
Kim, Jina(김진아)
Kim, Hojin(김호진) ORCID logo https://orcid.org/0000-0002-4652-8682
Park, Sang Joon(박상준)
Byun, Hwa Kyung(변화경) ORCID logo https://orcid.org/0000-0002-8964-6275
Yang, Gowoon(양고운)
Wee, Chan Woo(위찬우)
Lee, Jung-Yun(이정윤) ORCID logo https://orcid.org/0000-0001-7948-1350
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