EUCTR2012-004103-12-FR
Active, not recruiting
Not Applicable
ISOTOVE studyIsotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origin
Centre Jean Perrin0 sitesJune 11, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- peritoneal carcinomatosis of ovarian origin
- Sponsor
- Centre Jean Perrin
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age\> 18 years.
- •\-Performance status 0\-2
- •\- ANC\> 1\.5\.109 / L (without the addition of GCSF)
- •\-Platelets\> 100\. 109 / L
- •\-Bilirubin \-AST and ALT Alkaline\-Phosphatase \- Creatinine \-PTT \<1\.5 times the upper normal value (heparin, or other anticoagulants lovenox accepted)
- •\-PT/INR \- Patient operated first line without macroscopic residue for ovarian cancer or primary peritoneal or tubal stage IIIC peritoneal or pleural IV
- •\-Minimum required for surgery: hysterectomy, bilateral salpingo\-oophorectomy, omentectomy and pelvic lymphadenectomy para\-aortic
- •\- Patient requiring adjuvant chemotherapy
- •\- Compulsory affiliation to a social security scheme.
- •\- Obtaining informed consent in writing, signed and dated.
Exclusion Criteria
- •\-Patient aged 70 years and over
- •\- Patient with cognitive or psychiatric conditions.
- •\- Patient deprived of liberty by a court or administrative order.
- •\- Patient with indications against the realization of chemotherapy
- •\- Concomitant treatment with a drug test, participation in another therapeutic clinical trial \< 30 days
- •\- Pregnant Women
- •\- Breastfeeding
- •Sensory neuropathy, motor or \> grade 1 (CTCAE)
- •\-Hepatitis or severe infection requiring parenteral antibiotics
- •\- Serious non\-healing wound or ulcer, or bone fracture
Outcomes
Primary Outcomes
Not specified
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