EOADJUVANT CHEMOTHERAPY FOLLOWED BY SURGICAL DEBULKING AND INTRAPERITONEAL CHEMOHYPERTHERMIA FOR STAGE III OVARIAN CANCER. A PROSPECTIVE PHASE II STUDY - HIPEC_ovaio

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10033163Term: Ovarian epithelial cancer stage III; ovarian cancer

• Registration Number: EUCTR2007-005674-31-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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
-extra-abdominal spread of the disease
-hematogenous metastases (liver, lung, bone)
-age over 75 years
-performance status 4
-inadequate bone marrow function (WBC count < 3.0 x 109 L or platelet count < 100 x 109/L)
-inadequate renal function (serum creatinine level > 120 μmol/L or creatinine clearance < 60mL/min/1.73 m2)
-inadequate liver function (bilirubin level > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified