Retarded Surgery Following Neoadjuvant Chemotherapy in Advanced Ovarian Cancer
- Conditions
- Ovarian Cancer Stage IVOvarian Cancer Stage IIICOvarian Cancer Stage IIIb
- Registration Number
- NCT03579394
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- 211
Inclusion Criteria:<br><br> 1. Female patients =18 years.<br><br> 2. Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or<br> primary peritoneal carcinoma, high grade serous or endometrioïd, with the exception<br> of mucinous, clear cell and carcinosarcoma histologies.<br><br> 3. Performance status < 2 (see Appendix 2).<br><br> 4. Documented International Federation of Gynecologic Oncology (FIGO 2014, Appendix 1)<br> stage IIIB-IIIC-IVa unsuitable for complete primary cytoreductive surgery (confirmed<br> by open laparoscopy or by laparotomy [not mandatory for stage IVA]).<br><br> 5. Patient must be judged resectable after 3 courses of Neoadjuvant chemotherapy<br><br> 6. Adequate bone marrow, liver and renal function to receive chemotherapy and<br> subsequently to undergo surgery:<br><br> - White blood cells (WBC) >3x109/L, absolute neutrophil count (ANC) =1,5x109/L,<br> platelets (PLT)<br><br> =100x109/L, hemoglobin (Hb) =9 g/dL,<br><br> - Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance = 30<br> mL/min according to Cockroft-Gault formula or to local lab measurement, serum<br> bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.<br><br> 7. Signed informed consent obtained prior to any study-specific procedures.<br><br> 8. Patient affiliated to, or a beneficiary of, a social security category<br><br>Exclusion Criteria:<br><br> 1. Mucinous, clear cell , carcinosarcoma and low grade serous carcinomahistologies.<br><br> 2. Synchronous or previous other malignancies within 3 years prior to starting study<br> treatment, with the exception of adequately treated non-melanomatous skin cancer or<br> carcinoma in situ (of the cervix or breast or other sites).<br><br> 3. Patients with brain metastases, seizure not controlled with standard medical<br> therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic<br> attack (TIA) or subarachnoid hemorrhage before 6 months from the enrollment on this<br> study.<br><br> 4. Any other concurrent medical conditions contraindicating surgery or chemotherapy<br> that could compromise the adherence to the protocol (including but not limited to<br> impaired cardiac function or clinically significant cardiac diseases, active or<br> uncontrolled infections, HIV-positive patients on antiretroviral therapy,<br> uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired<br> respiratory function requiring oxygen-dependence, serious psychiatric disorders).<br><br> 5. Pregnant or breastfeeding women.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Free Survival
- Secondary Outcome Measures
Name Time Method EORTC QLQ-C30;Pathological complete response (PCR);Overall survival (OS);Time for first subsequent treatment (TFST);Post-operative mortality;Post-operative morbidity;Fagotti laparoscopic score;CTC-AE version 4.03 adverse events;questionnaire OV28
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