Epithelial ovarian carcinoma MedDRA version: 6.1 Level: PT Classification code 10033163
Conditions
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically proven ovarian carcinoma with evidence of residual tumour >= 1 cm after first surgery (carcinosis are included), advanced epithelial ovarian carcinoma, stages III and IV (documented by cytology or histology) presence of at least one indicator lesion to be used for assessment of response; the best indicator for response evaluation is surgery laparoscopy or laparotomy. other indicator lesions must meet criteria for measurable or evaluable disease and must be defined by radiological study (including CT or MRI scan) ultrasound, or chest x-ray) or physical exam. no previous chemo or radiotherapy females >18 anni performance status of 0 to 2 on ECOG scale Estimated life expectancy of at least 12 weeks. Adequate marrow function defined as WBC >=3 x 109, granulocytes >=1,5 x 109/L and platelets >=100 x 109/L, hemoglobin >=10 g/dl Adequate hepatic function defined as total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Epithelial ovarian carcinoma with residual tumour = 2. Concurrent treatment with other experimental drugs Significant neurological or psychiatric disorders that would prohibit patients to understanding or rendering informed consent or from fully complying with treatment and follow up. Hepatic functions abnormalities: AST and/or ALT >= 1,5 x UNL associated with alkaline phosphatase > 2,5 x UNL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the response rate between the three arm;Secondary Objective: To evaluate the progression free survival and survival rate at 3 years from first diagnosis of three following treatment regimens: paclitaxel combined with carboplatin on day 1 (arm A) versus carboplatin "induction" in high doses for two courses (arm B) or gemcitabine in high doses + paclitaxel weekly induction one course followed by paclitaxel, carboplatin (day 1) and gemcitabine (day 18) (arm C). to evaluate the time to progression of the three regimens. to determine the quantitative and qualitative toxicities of the two "induction" combination regimens (arm B and arm C).;Primary end point(s): Appraisal of objective answer between the three arms | — |
Countries
Italy
Outcome results
None listed