Efficacy of intraperitoneal chemohyperthermia associated with cytoreductive surgery in the peritoneal tube epithelial neoplasia / advanced-stage ovaria

Active, not recruiting

• Conditions: EPITHELIAL OVARIAN/TUBAL CANCER; MedDRA version: 14.1Level: HLTClassification code 10033121Term: Ovarian and fallopian tube cysts and neoplasmsSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002616-22-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO (A.O. DI RILIEVO NAZIONALE)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-07
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

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

Inclusion Criteria

1.Female adult women (18 to 70 years old) 2.patients, with EOC (FIGO stage IIIc, with a Fagotti modified Laparoscopic Scoring System = 4 3. who will show a complete clinical response (cCR) or partial clinical response (cPR) after 3 cycles (Carboplatin+Paclitaxel) of neoadjuvant chemotherapy; 4. performance status (ECOG) 0, 1 or 2 5. signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

refusing to sign an informed consent; • age > 70 years and age <18 years; • BMI > 35; • impossibility of an adequate follow-up; • presence of other active neoplasms; • active infection or other concurrent medical condition that could interfere in the ability of patients to receive the proposed treatment according to protocol; • extraabdominal metastases (Stage IV) ; • performance status (ECOG)>2; • complete bowel obstruction; • Abnormal bone marrow indices or renal and liver function; • ASA IV or V.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare two-years disease-free survival of CRS and HIPEC (CDDP+Paclitaxel) vs CRS alone in Stage IIIC unresectable epithelial tubal/ovarian cancer with partial or complete response after 3 cycles of 1st line chemotherapy (CBDCA +Paclitaxel).;Secondary Objective: ////;Primary end point(s): The present study will compare CRS + HIPEC (Cisplatin+Paclitaxel, CYHI) vs CRS alone (CYALONE) in Stage IIIC inoperable epithelial tubal/ovarian cancer with partial or complete response after neoadjuvant chemotherapy (3 cycles CDDP+Paclitaxel), followed by adjuvant chemotherapy in terms of two-years disease-free survival from the date of randomization.;Timepoint(s) of evaluation of this end point: 2 years-----