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Clinical Trial Protocols of Shanghai Gynecologic Oncology Group

-- SGOG OV4B/ SUNNY

Unique Protocol ID	SGOG OV4B
ClinicalTrials.gov ID	ClinicalTrials.gov Identifier: NCT02859038
Version Number	SGOG OV 4B (SOC-2) Version 4.0
IRB ID	B2015-136 (6) R
Data Monitoring Committee	Yes
Brief Title	Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients with Advanced Ovarian Cancer (SUNNY)
Official Title	Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients with Stage IIIC and IV Ovarian Cancer
Study Type	Interventional
Secondary IDs	SOC-2
Responsible Party	Shanghai Gynecologic Oncology Group
Sponsor	Shanghai Gynecologic Oncology Group
Collaborators	Zhejiang Cancer Hospital Sun Yet-Sen University Cancer Center Ajou University Hospital (KGOG) Seoul National University Hospital (KGOG) National Cancer Center Hospital East (JGOG) Tokyo Medical University Hospital (JGOG)
Brief Summary	The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
Study Start Date	August 2016
Primary Completion Date	June 2023
Study Completion Date	June 2024
Study Design	Allocation: Randomized Endpoint Classification: Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Outcome Measures	Primary Outcome: 1.Overall survival Secondary Outcome: 2.Progression-free survival The time from entry into the study to the diagnosis of the first progression or recurrence or death, whichever occurs first. 3.Post-operative complications The surgical complications will be evaluated at 30-day after upfront cytoreductive surgery or interval debulking surgery. 4.Quality of life assessments QOQ-C30, FACT-O (baseline; 6months, 12 months and 5 years after randomization) 5.Accumulating treatment-free survival (TFSa) The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, but maintenance of targeted agents is considered off-treatment. 6.Time to first subsequent anticancer therapy (TFST) The date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines. 7.Time to second subsequent anticancer therapy (TSST) The date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first. Maintenance treatments following a cytostatic treatment are NOT considered separate treatment lines. 8.The pattern of the first relapse The number and sites of the first relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups. 9.The rate of 5-year progression-free survival The rate of the patients without progression or recurrence or death at 5 years.
Keywords
Arms	1.Experimental: Upfront cytoreductive surgery Interventions: Upfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy. 2.Active Comparator: Neoadjuvant chemotherapy Intervention: Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy.
Intervention Description:	Procedure/Surgery: Upfront cytoreductive surgery Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5 Other Names: Primary debulking surgery, PDS Procedure/Surgery: Interval debulking surgery 3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy Other Names: NACT-IDS
Inclusion Criteria	•Women aged ≥ 18 years. •Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by laparoscopic biopsy, core needle biopsy or fine needle aspiration). (04/18/2019) If fine needle aspiration (FNA) or other cytological diagnosis showing an adenocarcinoma, patients should satisfy the following conditions: a). The patient has a pelvic mass, and b). Omental cake or other metastases larger than 2 cm in the 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 exclude metastatic ovarian cancer. •The Eastern Cooperative Oncology Group (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, hemoglobin ≥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	•Patients with non-epithelial tumors as well as borderline tumors. •Low-grade carcinoma. (09/22/2016) •Mucinous ovarian cancer. •Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity). (04/18/2019) •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.
Minimum Age	18 years old.
Maximum Age	None.
Accepts Healthy Volunteers	No.
Sample size	488 patients.
Central Contact	Rong Jiang, MD +86 21 64041990, jiang.rong@zs-hospital.sh.cn
Principal Investigators	Rongyu Zang, MD, PHD
Locations	China, Shanghai Zhongshan Hospital Fudan University Shanghai, Shanghai, China, 200032 Contact: Rong Jiang, MD +86 21 64041990, jiang.rong@zs-hospital.sh.cn Contact: Yuting Luan, RN +86 21 64041990, yutingluan@163.com Principal Investigator: Rongyu Zang, MD, PhD China, Zhejiang Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022 Contact: Jianqing Zhu, MD +86 571 8822222, zjq-hz@126.com China, Shanghai Shanghai First Maternity and Infant Hospital Affiliated to Tongji University Shanghai, Shanghai, China, 200040 Contact: Xipeng Wang, MD, PhD +86 21 20261000 Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai, Shanghai, China, 200092 Contact: Xipeng Wang, MD, PhD +86 21 25078999 China, Guangdong Sun Yet-Sen University Cancer Center Guangzhou, Guangdong, China, 510060 Contact: Jihong Liu, MD, PhD +86 20 87343392, liujih@mail.sysu.edu.cn South Korea Ajou University Hospital Suwon, South Korea Contact: JinHee Kim, BSN koreagynonco@hanmail.net Seoul National University Hospital Seoul, South Korea Contact: MyungHee Nam, RN +82 220721922 China Hunan Provincial Hospital Changsha, China Contact: Ding Zhu, MD +86 731 83929342
Recruitment Status	Active, recruiting complete