Spots Global Cancer Trial Database for Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
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Trial Identification
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 ID: NCT02859038
Study Description
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?
Detailed Description: OBJECTIVES: Compare the efficacy and safety in patients with AJCC TNM 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. OUTLINE: This is a randomized phase III multicenter study. Patients 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. Patients are followed every 3 months within the first 5 years, and then every 6 months. PROJECTED ACCRUAL: A total of 488 patients will be accrued for this study within 5 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Sun Yet-Sen University Cancer Center, Guangzhou, Guangdong, China
Zhongshan Hospital Fudan University, Shanghai, Shanghai, China
Shanghai First Maternity and Infant Hospital Affiliated to Tongji University, Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Hunan Provincial Hospital, Changsha, , China
Seoul National University Hospital, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Contact Details
Name: Rongyu Zang, MD,PHD
Affiliation: Fudan University Shanghai Zhongshan Hospital
Role: PRINCIPAL_INVESTIGATOR
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