ovarian cancer MedDRA version: 9.1 Level: LLT Classification code 10033163 Term: Ovarian epithelial cancer stage III
Conditions
Interventions
Trade Name: TAXOL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Paclitaxel
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: - pathologically diagnosed primary ovarian cancer - stage III (extra-pelvic microscopic or macroscopic peritoneal dissemination of the disease), as defined by laparoscopic and radiological staging Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA - extra-abdominal spread of the disease - hematogenous metastases (liver, lung, bone) - age over 75 years - performance status 4 - inadequate bone marrow function (WBC count 120 μmol/L or creatinine clearance 25 μmol/L) - history of ventricular arrhythmia, congestive hearth failure, or documented myocardial infarction within the 6 months preceding the inclusion in the study - positive anamnesis for allergic reactions to drugs containing Cremophor EL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main aim of this phase II prospective study is the evaluation of the effectiveness of neoadjuvant chemotherapy followed by surgical debulking and intraperitoneal chemohyperthermia in patients with stage III primary ovarian cancer. Long-term survival, disease-free survival and quality of life will be evaluated and compared with an age-matched control group of patients previously submitted to standard conventional treatment (surgery and systemic chemotherapy). Statistical analysis of sample size identified 60 patients for each group as an adequate number in order to observe a statistical significance in long-term survival.;Secondary Objective: Secondary objectives are the evaluation of toxicity and postoperative complications of this advanced treatment, the selection of patients responders to neoadjuvant chemotherapy with cisplatin and taxanes, and the analysis of factors potentially associated with early and long-term results.;Primary end point(s): PRIMARY END-POINT: assessment of long-term results in patients with stage III ovarian cancer submitted to neoadjuvant chemotherapy, surgical debulking and intraperitoneal chemohyperthermia; comparison with control group (conventional treatment) | — |
Countries
Italy
Outcome results
None listed