Standard of care therapy with or without stereotactic ablative radiation therapy for recurrent ovarian cancer (SABR-ROC): a prospective randomized phase III trial (KGOG 3064/KROG 2204)

초록

Introduction Despite the controversial role of radiotherapy (RT) in recurrent ovarian cancer (ROC), there might be a survival benefit irrespective of favorable clinical features according to a preliminary analysis. This prospective study was designed to compare the survival outcomes between standard of care (SOC) with or without stereotactic ablative RT (SABR) to all recurrent sites in ROC. Methods Patients with recurrent epithelial ovarian cancer with 10 or less metastatic sites at recurrence based on the number of SABR fields are eligible. Those who have a history of RT, single lesion sized >5 cm, or diffuse peritoneal carcinomatosis are not eligible. Patients will be stratified by factors as the followings; number of favorable factors (absence of ascites, platinum-sensitivity, CA-125, and ECOG performance), location of the lesion (lymph node vs. non-lymph node), and use of PARP inhibitor. Patients will be randomized (1:2) into SOC salvage treatment (arm 1) vs. SOC plus metastasis-directed SABR (arm 2). The primary endpoint is 3-year overall survival rate (58.5% for arm 1 and 74.4% for arm 2). A total of 270 patients will be required. Current Trial Status A dummy-run study involving 4 representative clinical scenarios is under progress. To enhance compliance with the protocols, a three-tiered RT quality assurance (QA) process consisting of general credentialing, trial-specific credentialing with dummy run plus phantom QA, and individual case review has been performed. Currently, 32 patients from 16 sites are enrolled as of August 21st, 2023.