Randomized controlled trial of Primary Debulking Surgery (PDS) and Neoadjuvant Chemotherapy + Interval Debulking Surgery (NAC / IDS) in patients with stage IIIC / IV ovarian cancer
- Conditions
- Ovarian cancer, Fallopian tube cancer, primary peritoneal cancerOvary, fallopian tube, peritoneum
- Registration Number
- JPRN-jRCTs051190090
- Lead Sponsor
- Kato Kazuyoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 488
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method 1. progression free survival<br>2 QOL<br>3. treatment-free interval<br>4. 30 days postoperative complications<br>5. Comparison of time to recurrence