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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)

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dc.contributor.author김용배-
dc.contributor.author김호진-
dc.contributor.author변화경-
dc.contributor.author위찬우-
dc.contributor.author이정윤-
dc.contributor.author양고운-
dc.contributor.author김진아-
dc.contributor.author박상준-
dc.date.accessioned2024-01-03T00:19:16Z-
dc.date.available2024-01-03T00:19:16Z-
dc.date.issued2023-10-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/197231-
dc.description.abstractBackground: 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.-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherBioMed Central-
dc.relation.isPartOfBMC CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAged-
dc.subject.MESHCarcinoma, Ovarian Epithelial / radiotherapy-
dc.subject.MESHClinical Trials, Phase III as Topic-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMulticenter Studies as Topic-
dc.subject.MESHNeoplasm Recurrence, Local / etiology-
dc.subject.MESHNeoplasm Recurrence, Local / radiotherapy-
dc.subject.MESHOvarian Neoplasms* / etiology-
dc.subject.MESHOvarian Neoplasms* / radiotherapy-
dc.subject.MESHProspective Studies-
dc.subject.MESHRadiosurgery* / methods-
dc.subject.MESHRandomized Controlled Trials as Topic-
dc.subject.MESHStandard of Care-
dc.titleStudy 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)-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Radiation Oncology (방사선종양학교실)-
dc.contributor.googleauthorYong Bae Kim-
dc.contributor.googleauthorHwa Kyung Byun-
dc.contributor.googleauthorChan Woo Wee-
dc.contributor.googleauthorHojin Kim-
dc.contributor.googleauthorSeyoung Kim-
dc.contributor.googleauthorGowoon Yang-
dc.contributor.googleauthorJina Kim-
dc.contributor.googleauthorSang Joon Park-
dc.contributor.googleauthorJung-Yun Lee-
dc.identifier.doi10.1186/s12885-023-11407-y-
dc.contributor.localIdA00744-
dc.contributor.localIdA05970-
dc.contributor.localIdA05136-
dc.contributor.localIdA06487-
dc.contributor.localIdA04638-
dc.relation.journalcodeJ00351-
dc.identifier.eissn1471-2407-
dc.identifier.pmid37864152-
dc.subject.keywordOverall survival-
dc.subject.keywordRecurrent ovarian cancer-
dc.subject.keywordSABR-
dc.contributor.alternativeNameKim, Yong Bae-
dc.contributor.affiliatedAuthor김용배-
dc.contributor.affiliatedAuthor김호진-
dc.contributor.affiliatedAuthor변화경-
dc.contributor.affiliatedAuthor위찬우-
dc.contributor.affiliatedAuthor이정윤-
dc.citation.volume23-
dc.citation.number1-
dc.citation.startPage1014-
dc.identifier.bibliographicCitationBMC CANCER, Vol.23(1) : 1014, 2023-10-
Appears in Collections:
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

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