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Clinical Trials/EUCTR2012-004103-12-FR
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.

Registry
who.int
Start Date
June 11, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Centre Jean Perrin

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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