Randomized phase III study evaluating hyperthermic intraperitoneal chemotherapy in the treatment of ovarian cancer relapse

• Conditions: Ovarian epithelial Cancer: intraperitoneal resectable relapse; MedDRA version: 14.1Level: 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-ES
• Lead Sponsor: nicancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 444

Inclusion Criteria

1.Patient age ? 18 years,
2.Performance Status WHO < 2,
3.Previous treatment for epithelial ovarian cancer,
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,
6.Complete cytoreductive surgery,
7.Delay between the last cycle of second-line chemotherapy and surgery must be between 5 and 8 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/mn) calculated with MDRD method.
10. Hematological functions : PNN ? 1.5x109/L, platelets ? 100x109/L,
11. No contraindication to general anesthesia,
12.Patient must be informed and the Informed Consent Form signed before any study-specific 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 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

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,
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

Study & Design

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