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Randomized controlled trial of Primary Debulking Surgery (PDS) and Neoadjuvant Chemotherapy + Interval Debulking Surgery (NAC / IDS) in patients with stage IIIC / IV ovarian cancer

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051190090
Enrollment
488
Registered
2019-12-25
Start date
2020-06-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer, Fallopian tube cancer, primary peritoneal cancer Ovary, fallopian tube, peritoneum

Interventions

Administration of antineoplastic agents
antineoplastic agents,

Sponsors

Kato Kazuyoshi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
1. progression free survival 2 QOL 3. treatment-free interval 4. 30 days postoperative complications 5. Comparison of time to recurrence

Countries

China, Japan, Korea

Contacts

Public ContactKazuyoshi Kato

Kitasato University Hospital

kazuyosikato@gmail.com+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026