JPRN-jRCTs051190090
Active, not recruiting
Phase 3
Randomized phase III controlled trial of Primary Debulking Surgery (PDS) and Neoadjuvant Chemotherapy + Interval Debulking Surgery (NAC / IDS) in patients with stage IIIC / IV ovarian cancer - SUNNY trial
Kato Kazuyoshi0 sites488 target enrollmentDecember 25, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Ovarian cancer, Fallopian tube cancer, primary peritoneal cancer
- Sponsor
- Kato Kazuyoshi
- Enrollment
- 488
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subjects of this study are patients who meet the following requirements.
- •1\. Women over 18
- •2\. Pathologically confirmed stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- •3\. ECOG performance status 0\- 2
- •4\. ASA score 1\-2
- •5\. Patients who have the bone marrow function, liver function and kidney function that are applicable to chemotherapy and surgery
- •6\. Patients who can comply with the study plan and follow\-up
- •7\. Patients for whom written consent was obtained
Exclusion Criteria
- •Patients who fall under any of the following are excluded from this study:
- •1\. Patients with non\-epithelial tumor or borderline malignant tumor
- •2\. patients with low\-grade carcinoma
- •3\. Patients with ovarian mucinous carcinoma
- •4\. Patients with synchronous or metachronous (within 5 years) malignancy other than breast cancer with carcinoma in situ or no signs of recurrence or activity
- •5\. Patients who have contraindications for surgery or chemotherapy that may impair compliance with the protocol
- •6\. Patients who have informed consent, study procedures, religions that may inhibit follow\-up, mental factors etc.
Outcomes
Primary Outcomes
Not specified
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