_

• Conditions: Ovarian epithelial cancer : intraperitoneal resectable relapse; MedDRA version: 17.1Level: PTClassification code 10033160Term: Ovarian epithelial cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-023035-42-IT
• Lead Sponsor: ICANCER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-23
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient age = 18 years,
2. Performance Status WHO < 2,
3. Previous treatment for epithelial ovarian cancer, tubal peritoneal primitive
4. Patient with intraperitoneal relapse (more than 6 months after the end of the initial treatment), resectable without distant metastasis (with the exception of communicating pleura effusion, sensitive to platine-based second line chemotherapy and resectable
lymph-nodes in the groin or retro peritoneal) ,
5. Second-line platinum-based pre-operatory chemotherapy: carboplatin-paclitaxel or carboplatin-caelix (pegylated liposomal doxorubicine: with gemcitabine, trabectidine, hycamtin authorized)
6. Complete cytoreductive surgery,
7. Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 12 weeks
8. No hepatic insufficiency (bilirubin = 1.5 the Upper Limit of Normal (ULN), ASAT and ALAT = 3 ULN,
9. No renal insufficiency (creatinine = 1.5 ULN, creatinine clearance >60 ml/min) calculated with MDRD method,
10. Hematological functions : PNN ³ 1.5x109/L, platelets ³ 100x10^9/L,
11. No contraindication to general anesthesia for heavy surgery
12. Patient must be informed and the Informed Consent Form signed before any studyspecific procedures start.
13. Medical/Public Health insurance coverage
14. Women of child-bearing age must use appropriate contraception during treatment and for 6 months after the end of treatment.
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 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

Exclusion Criteria

1) Patient age <18 years,
2) Previous cancer in the last 5 years (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma),
3) Known hypersensitivity to cisplatin,
4) Metastasis,
5) Use of anti-angiogenic treatment within 8 weeks before surgery
6) Patient with other concomitant severe life threatening disease,
7) More than 2 segmental resections concomitant to HIPEC is foreseen,
8) Any progressive disease during the second-line chemotherapy (platine-based),
9) Relapse occurring less than 6 months after the end of the initial treatment,
10) Non-epithelial ovarian tumor,
11) Uncontrolled infection,
12) Patient unwilling or in the incapacity to comply with the medical follow-up required by the trial because of geographic, social or psychological reasons.
13) Clinically significant cardiorespiratory disease contraindicating the hyper hydration required for HIPEC,
14) Patient who has already been treated by HIPEC for ovarian cancer,
15) Persons kept in detention, or incapable of giving consent, or without a Public Health insurance coverage,
16) Pregnant or breastfeeding woman
17) Patient who has already been enrolled in another clinical trial

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To improve overall survival at 12 months for patients in arm with HIPEC compared with patients in arm without HIPEC.;Secondary Objective: TO EVALUATE:<br>- Relapse-free survival.<br>- Quality of life and pain: QLQ C30 and FACT O forms (functional assessment of cancer therapy for ovarian cancer) and Visual Analogue Scale (VAS).<br>- Treatment related toxicities (CTC-AE v4.0) including renal toxicities.<br>- Morbidity.<br><br>TO PERFORM:<br>- Medico-economic study: collection of socio-demographic data and patient-related management costs.;Primary end point(s): The date of death, whatever its cause, will be the main parameter used to evaluate overall survival.;Timepoint(s) of evaluation of this end point: _