Clinical trial · Interventional
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
NCT02859038CI-TRIAL-00085680active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to answer the fundamental question, should the physicians choose Surgery or Chemotherapy (SOC-2) in advanced ovarian cancer?
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Primary Peritoneal Carcinoma | Primary Peritoneal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interval debulking surgery | Procedure | — | UNRESOLVED |
| Upfront cytoreductive surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Upfront cytoreductive surgery
- description
- Upfront cytoreductive surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy.
- interventionNames
- Procedure: Upfront cytoreductive surgery
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemotherapy
- description
- neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy.
- interventionNames
- Procedure: Interval debulking surgery
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJiang R, Zhu J, Kim JW, Liu J, Kato K, Kim HS, Zhang Y, Zhang P, Zhu T, Aoki D, Yu A, Chen X, Wang X, Zhu D, Zhang W, Jia H, Shi T, Gao W, Yin S, Feng Y, Xiang L, Okamoto A, Zang R. Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept. J Gynecol Oncol. 2020 Sep;31(5):e86. doi: 10.3802/jgo.2020.31.e86. PMID 32808504