Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept

Rong Jiang, Jianqing Zhu, Jae Weon Kim, Jihong Liu, Kazuyoshi Kato, Hee Seung Kim, Yuqin Zhang, Ping Zhang, Tao Zhu, Daisuke Aoki, Aijun Yu, Xiaojun Chen, Xipeng Wang, Ding Zhu, Wei Zhang, Huixun Jia, Tingyan Shi, Wen Gao, Sheng Yin, Yanling FengLibing Xiang, Aikou Okamoto, Rongyu Zang

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in 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 in stages 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 in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02859038.

Original languageEnglish
Pages (from-to)e86
JournalJournal of gynecologic oncology
Volume31
Issue number5
DOIs
Publication statusPublished - 2020 Sep 1

Keywords

  • Cytoreduction Surgical Procedures
  • Neoadjuvant Therapy
  • Ovarian Cancer

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynaecology

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    Jiang, R., Zhu, J., Kim, J. W., Liu, J., Kato, K., Kim, H. S., Zhang, Y., Zhang, P., Zhu, T., Aoki, D., Yu, A., Chen, X., Wang, X., Zhu, D., Zhang, W., Jia, H., Shi, T., Gao, W., Yin, S., ... Zang, R. (2020). Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept. Journal of gynecologic oncology, 31(5), e86. https://doi.org/10.3802/jgo.2020.31.e86