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- 저자 : Huixun Jia (검색결과 1 건)
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Rong Jiang,Jianqing Zhu,김재원,Jihong Liu,Kazuyoshi Kato,김희승,Yuqin Zhang,Ping Zhang,Tao Zhu,Daisuke Aoki,Aijun Yu,Xiaojun Chen,Xipeng Wang,Ding Zhu,Wei Zhang,Huixun Jia,Ting-Yan Shi,Wen Gao,Sheng Yin,Yan 대한부인종양학회 2020 Journal of Gynecologic Oncology Vol.31 No.5
Background: Two randomized phase III trials (EORTC55971 and CHORUS) showed similarprogression-free and overall survival in primary or interval debulking surgery in ovariancancer, however both studies had limitations with lower rate of complete resection and lack ofsurgical qualifications for participating centers. There is no consensus on whether neoadjuvantchemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approachin the management of advanced epithelial ovarian cancer (EOC) in the clinical practice. Methods: The Asian SUNNY study is an open-label, multicenter, randomized controlled,phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS instages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC). The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS inadvanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS inthe treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of nogross residual (NGR) in PDS group in all centers and participating centers should be nationalcancer centers or designed ovarian cancer section or those with the experience participatingsurgical trials of ovarian cancer. Any participating center should be monitored evaluatingthe proportions of NGR by a training set. The aim of the surgery in both arms is maximalcytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy orpositron emission tomography/computed tomography scan. Patients assigned to PDS groupwill undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal timeinterval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusioncriteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performancestatus of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as wellas borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456subjects. Primary endpoint is overall survival. Trial Registration: ClinicalTrials.gov Identifier: NCT02859038
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