Malignant neoplasm of ovary
Conditions
Interventions
ARM A (control arm): 105 patient will receive 3 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks followed by cytoreductive surgery within 6 weeks from the last cycle of chemoth
Drug
Procedure/surgery
Sponsors
Vanessa da Costa Miranda
Instituto do Cancer do Estado de Sao Paulo
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective is evaluate Disease Free Survival (DFS) than surgery after 3 courses of neoadjuvant chemotherapy (NACT). DFS is defined as the time interval between randomization and recurrence (local/distant) or second cancer or death (all causes), | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate if there is increase in Health Related Quality of Life (HR-QoL). Assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and OV28 ;Evaluate if there is increase in pathological complete response rate after 6 versus 3 cycles of neoadjuvant chemotherapy. We will consider pathological complete response the absence ou residual disease;Evaluate if there is increase in overall survival after 6 versus 3 cycles of neoadjuvant chemotherapy. We will consider overall survival the difference between randomization and death;Evaluate if there is increase in time for first subsequent treatment after 6 versus 3 cycles of neoadjuvant chemotherapy. We will consider overall survival the difference between the end of the protocol treatment and beginning of new treatment.;Evaluate if there is increase in post operative morbity and mortality (according to Clavien Dindo scoring) after 6 versus 3 cycles of neoadjuvant chemotherapy. ;Evaluate if there is increase in toxicity after 6 versus 3 cycles of neoadjuvant chemotherapy. Toxicity will be checked according Common Terminology Criteria for Adverse Events version 4.03 ;Evaluate if there is increase in complete cytoreduction rate after 6 versus 3 cycles of neoadjuvant chemotherapy. Complete cytoreduction rate will be considered as no residual disease after surgery | — |
Countries
Brazil
Contacts
Public ContactVanessa Miranda
Instituto do Cancer do Estado de Sao Paulo
Outcome results
None listed