SUNNY.

Study name	Study of upfront surgery versus neoadjuvant chemotherapy in patients with advanced ovarian cancer (SUNNY) in China and Korea
Methods	To compare the efficacy and safety in women with FIGO (2014) stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer, or peritoneal carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront surgery. A randomised phase III multi‐centre study
Participants	A total of 456 women will be accrued for this study within 5 years. Inclusion criteria Age ≥ 18 years. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration*). Laparoscopic biopsy with pictures is recommended. * If fine needle aspiration showing an adenocarcinoma, women should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra‐abdominal metastasis, and c. serum CA125/CEA ratio>25. If serum CA125/CEA ratio<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer. ECOG performance status of 0 to 2 ASA score of 1 to 2 Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery White blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, haemoglobin ≥9 g/dL Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft‐Gault formula or to local lab measurement Serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) < 2.5 x UNL Comply with the study protocol and follow‐up Written informed consent Exclusion Criteria Women with non‐epithelial tumours as well as borderline tumours Mucinous ovarian cancer Low‐grade ovarian cancer Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow‐up
Interventions	Women will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy. Women are followed every 3 months within the first 5 years, and then every 6 months.
Outcomes	Primary outcome measure OS Secondary outcome measures PFS Postoperative complications ‐ the surgical complications will be evaluated at 30‐day after upfront cytoreductive surgery or interval debulking surgery QoL assessments using QOQ‐C30 questionnaire
Starting date	December 2015
Contact information	Rong Jiang, MD ‐ jiang.rong@zs‐hospital.sh.cn Yuting Luan, RN ‐ yutingluan@163.com
Notes	Estimated study completion date December 2022

ALT: alanine aminotransferase; ASCO: American Society of Clinical Oncology; AST: aspartate aminotransferase; CI: confidence interval; CR: complete response; ECOG PS: Eastern Cooperative Oncology Group Performance Scale; EOC: epithelial ovarian carcinoma; HR: hazard ratio; ICU: intensive care unit; NACT: neoadjuvant chemotherapy; OS: overall survival; PDS: primary debulking surgery; PFS: progression‐free survival; QoL: quality of life; RCT: randomised controlled trial.