RBR-3y869jRecruitingPhase 2
Retarded surgery following neoadjuvant chemotherapy in advanced ovarian cancer
Vanessa da Costa Miranda0 sitesStarted: December 6, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Intervention
Eligibility Criteria
- Ages
- 18Y to — (—)
- Sex
- Female
Inclusion Criteria
- •A subject will be considered eligible for inclusion in this study if all the following criteria are met: Female patients more than 18 years;
- •histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception of mucinous, clear cell and carcinosarcoma histologies; performance status less than 2; documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1) stage IIIB-IIIC-IV unsuitable for complete primary cytoreductive surgery (confirmed by open laparoscopy or by laparotomy); patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy; adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery: white blood cells (WBC) more than 3x109/L, absolute neutrophil count (ANC) more than 1,5x109/L, platelets (PLT) more than 100x109/L, hemoglobin (Hb) more than 9 g/dL, serum creatinine less than 1.25 x upper normal limit (UNL) or creatinine clearance more than 30 mL/min, serum bilirubin less than 1.25 x UNL, AST(SGOT) and ALT(SGPT) less than 2.5 x UNL; signed informed consent obtained.
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study: Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies; synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites); patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study; any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol; pregnant or breastfeeding women.
Investigators
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