Clinical Trials in South Korea / NCT02859038
Active, not recruiting
Phase 3
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
NCT02859038 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
Investigational drug(s) / intervention(s)
Upfront cytoreductive surgeryInterval debulking surgery
Upfront cytoreductive surgery: Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
Interval debulking surgery: 3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy
Study 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?
Eligibility
Inclusion Criteria:
1. Women aged ≥ 18 years.
2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or fine needle aspiration\*). Laparoscopic biopsy with pictures is recommended.
\* If fine needle aspiration showing an adenocarcinoma, patients should satisfy the following conditions: a. the patient has a pelvic mass, and b. omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis, and c. serum CA125/CEA ratio\>25. If serum CA125/CEA ratio\<25 or malignancies of other origins, such as breasts and digestive tract, are suspected from symptoms, physical examinations or imaging diagnosis, endoscopy or ultrasonography should be done to exclusive metastasis ovarian cancer.
3. ECOG performance status of 0 to 2.
4. ASA score of 1 to 2.
5. Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
1. white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
2. serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
3. serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
6. Comply with the study protocol and follow-up.
7. Written informed consent.
Exclusion Criteria:
1. Patients with non-epithelial tumors as well as borderline tumors.
2. Mucinous ovarian cancer.
3. Low grade ovarian cancer.
4. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
5. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
6. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Primary outcome measure(s)
- Overall survival — Participants will be followed for at least 5 years after randomization or until death
The time from entry into the study to any cause of death.
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Sun Yet-Sen University Cancer Center | Guangzhou | Guangdong | |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | |
| Shanghai First Maternity and Infant Hospital Affiliated to Tongji University | Shanghai | Shanghai Municipality | |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | |
| Hunan Provincial Hospital | Changsha | China | |
| Seoul National University Hospital | Seoul | South Korea | |
| Ajou University Hospital | Suwon | South Korea |
Other trials for the same condition
Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02859038 on ClinicalTrials.gov ↗ ← All trials in South Korea