Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Carcinoma
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
OBJECTIVES: Compare the efficacy and safety in patients 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. OUTLINE: This is a randomized phase...
OBJECTIVES: Compare the efficacy and safety in patients 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. 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 456 patients will be accrued for this study within 5 years.
Tracking Information
- NCT #
- NCT02859038
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Rongyu Zang, MD,PHD Fudan University Shanghai Zhongshan Hospital
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