Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer… (NCT02859038) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Upfront Surgery Versus Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer (SUNNY)
China489 participantsStarted 2016-08
Plain-language 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?
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. 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:
✓. 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.
Exclusion criteria
✕. Patients with non-epithelial tumors as well as borderline tumors.
✕. Mucinous ovarian cancer.
✕. Low grade ovarian cancer.
✕. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
✕. Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
What they're measuring
1
Overall survival
Timeframe: Participants will be followed for at least 5 years after randomization or until death
✕. Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.