NCT02859038Active, not recruitingPhase 3
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Patients With Stage IIIC and IV Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 10 Feb 2025
Brief summary (registry, in English)
The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 489 (actual)
- First submitted
- 23 Jul 2016
- Start date
- Aug 2016
- Primary completion date
- Jun 2027
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Diseases
- Ovarian cancer
- NCT number
- NCT02859038
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 489
- From Aug 2016 to the primary completion date, Jun 2027
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
Other illness
- Mucinous ovarian cancer.
- Low grade ovarian cancer.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Other
- Patients with non-epithelial tumors as well as borderline tumors.
Who the study is looking for
- Women aged ≥ 18 years.
- 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.
- ECOG performance status of 0 to 2.
- ASA score of 1 to 2.
- Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
- white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- 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,
- serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
- Comply with the study protocol and follow-up.
- Written informed consent.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Provincial Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sun Yet-Sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shanghai First Maternity and Infant Hospital Affiliated to Tongji University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.