SGOG OV7 - SGOG门户网站

Unique Protocol ID	SAT-1 (SGOG OV007)
ClinicalTrials.gov ID	NCT 05200260
Version Number	V3.0
IRB ID	B2022-087(5) (approved by the ethics committees of Zhongshan Hospital, Fudan University)
Brief Title:	Surgery Combined with Maintenance Targeted Therapy in the Treatment of Advanced Ovarian Cancer
Official Title：	A Prospective, Multicenter, Randomized Phase II Trial on Optimal Timing of Surgery Combined with Maintenance Therapy in the Treatment of Advanced Ovarian Cancer
Study Type：	Interventional
Secondary IDs	None
Responsible Party：	Shanghai Gynecologic Oncology Group
Sponsor:	Shanghai Gynecologic Oncology Group
Collaborators:	Zhongshan Hospital, Fudan University, Shanghai, China Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China Sun Yet-Sen University Cancer Center, Guangzhou, Guangdong, China Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China Fudan University Cancer Hospital, Shanghai, China Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China The First Affiliated Hospital of University of Science and Technology of China, Anhui, China The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China The First People's Hospital of Foshan, Guangdong, China
Brief Summary:	The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' combined with PARP inhibitor in advanced ovarian cancer patients.
Detailed Description:	The purpose of this trial is to answer the fundamental question 'The Optimal Timing of Surgery' combined with Bevacizumab or Poly-adenosine Ribose Phosphate Inhbitors (PARPi), in the circumstance of primarily diagnosed advanced epithelial ovarian cancer, fallopian tube cancer and primary peritoneal carcinoma.
Study Start Date:	Jul 2022
Primary Completion Date：	Jun 2027 (final data collection date for primary outcome measure)
Study Completion Date:	Jun 2027 (final data collection date for study)
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Outcome Measures:	Primary Outcome: l 3-year overall survival The proportion of patients alive at 3 years after entry into the study [Time Frame: Participants will be followed for at least 3 years after randomization] Secondary Outcomes: l Overall survival The time from date of randomization until the date of death from any cause [Time Frame: Participants will be followed for at least 3 years after randomization] l Progression free survival The time from date of randomization until the diagnosis of the first progression or recurrence or death, whichever occurs first [Time Frame: Participants will be followed for at least 3 years after randomization] l Post-operative complications The surgical complications will be evaluated 30-day, 60-day and 90-day after upfront cytoreductive surgery or interval debulking surgery [Time Frame: Participants will be followed up to 3 months after randomization] l Quality of life assessments QLQ-C30, FACT-Q (baseline; 6 months, 12 months, 24 months and 36 months after randomization) [Time Frame: Participants will be followed for at least 3 years after randomization] l Accumulated treatment-free survival Time from the date of randomization to death from any reason, minus the total treatment time of surgery and chemotherapy after randomization (regardless of targeted therapy) [Time Frame: Participants will be followed for at least 3 years after randomization] l TFST Time from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first [Time Frame: Participants will be followed for at least 3 years after randomization] l TSST Time from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurred first [Time Frame: Participants will be followed for at least 3 years after randomization] l Patterns of the 1^st recurrence The number and sites of the 1^st relapse, including pelvic, abdominal, retroperitoneal lymph nodes, distant metastases and ascites will be compared between the two groups. [Time Frame: Participants will be followed for at least 3 years after randomization]
Conditions	Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma
Keywords:	Ovarian Cancer; Primary Debulking Surgery; Neoadjuvant chemotherapy; Poly-adenosine Ribose Phosphate Inhbitors (PARPi); Bevacizumab
Arms:	Experimental: Upfront cytoreductive surgery with maintenance therapy Active Comparator: Neoadjuvant chemotherapy with maintenance therapy
Interventions:	Experimental Arm: Procedure/Surgery: Primary debulking surgery Primary debulking 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. Drug: PARP inhibitor For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy. Other Names: Olaparib Drug: Bevacizumab For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy. Active Comparator: Procedure/Surgery: Neoadjuvant chemotherapy 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. Drug: PARP inhibitor For patients with BRCA mutated, maintenance therapy of PARP inhibitors following CR/PR after first-line chemotherapy. In this trial, Olaparib 300mg p.o. twice daily is suggested after the front-line therapy. Other Names: Olaparib Drug: Bevacizumab For patients without BRCA mutated, maintenance therapy of Bevacizumab following CR/PR after first-line chemotherapy. In this trial, Bevacizumab 7.5mg per kilogram intravenous once every 3 weeks is suggested after the front-line therapy.
Eligibility Criteria:	Inclusion Criteria: · Females aged ≥ 18 years. · Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma · Low, Middle tumor burden and High tumor burden with cPCI score ≤ 12 based on pre-operative CT or PET/CT examination · Complete cytoreduction can be achieved based on CT or PET/CT examination · Performance status (ECOG 0-2) · Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent 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. Patients who have given their written informed consent. Exclusion Criteria: · Non-epithelial ovarian malignancies and borderline tumors · Low grade ovarian cancer · Mucinous ovarian cancer · Complete cytoreduction cannot be achieved according to preoperative evaluation including pulmonary and hepatic parenchymal metastases, unresectable extensive pleural metastases, multiple thoracic lymph nodes metastases, brain or bone metastases · Patient has a known hypersensitivity to the components of olaparib/bevacizumab or its excipients. · Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, thyroid carcinoma, or breast carcinoma (without any signs of relapse or activity, early-stage). 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.
Gender：	Female
Minimum Age:	18 Years
Maximum Age:	Not limited
Accepts Healthy Volunteers:	No
Sample size	208
Central Contact：	Libing Xiang, MD 862164041990 ext 2801 xiang.libing@zs-hospital.sh.cn
Principal Investigators	Libing Xiang, MD, PhD Tel: 862164041990 ext 2801 Email: xiang.libing@zs-hostial.sh.cn
Locations:	Recruiting site: Zhongshan Hospital, Fudan University, Shanghai, China Contact: Libing Xiang 862164041990 Ext. 2801 xiang.libing@zs-hospital.sh.cn Principal Investigator: Libing Xiang Zhejiang Cancer Hospital, Hangzhou, China Contact: Yingli Zhang zhangyl@zjcc.org.cn Sun Yet-Sen University Cancer Center, Guangzhou, China Contact: Chuyao Zhang zhangchy@sysucc.org.cn Fudan University Cancer Hospital, Shanghai, China Contact: Huijuan Yang huijuanyang@hotmail.com Obstetrics and Gynecology Hospital of Fundan University, Shanghai, China Contact: Wei Jiang jiangwei1436@fckyy.org.cn Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Contact: Xipeng Wang xipengwang@hotmail.com The First Affiliated Hospital of University of Science and Technology of China, Hefei, China Contact: Ying Zhou caddiezy@ustc.edu.cn The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China Contact: Jianhua Qian qianjianhua@zju.edu.cn The First People's Hospital of Foshan, Foshan, China Contact: Songhua Yuan yuan-sh09@163.com
Recruitment Status:	Recruiting