ISOTOVE studyIsotopic study of the intraperitoneal distribution of locoregional post surgery chemotherapy for peritoneal carcinomatosis of ovarian origi

• Conditions: peritoneal carcinomatosis of ovarian origin; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004103-12-FR
• Lead Sponsor: Centre Jean Perrin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-11
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

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

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.

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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
-Abdominal fistula or gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to intraperitoneal chemotherapy
-Clinical symptoms or signs of gastrointestinal obstruction and / or require hydration and / or parenteral nutrition
-Patients who have had or are currently having an inflammatory disease of the bowel
- Active bleeding or pathological condition that carries a high risk of bleeding (eg, bleeding disorders known coagulopathy, or tumor with large vessels)
- Stroke (CVA) or transient ischemic attack, or subarachnoid hemorrhage within the past 6 months
- Cardiovascular disease clinically significant, including:
o Uncontrolled hypertension, defined as systolic blood pressure> 150 mm Hg or diastolic> 90 mm Hg
o myocardial infarction or unstable angina within the past 6 months
o NYHA class II-IV congestive heart failure
o serious cardiac arrhythmia requiring treatment:
-Asymptomatic atrial fibrillation with controlled ventricular or supraventricular tachycardia controlled with medication and is authorized asymptomatic
o Peripheral vascular disease = grade 2 (CTCAE) (short [less than 24 hours] episodes of ischemia managed non-surgically and without permanent deficit)

-History hemorrhage or cerebral vascular accident (CVA), transient ischemic attack, or subarachnoid in the last 6 months

-Major surgery within 28 days before enrollment

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: -Evaluate the anatomical distribution of the isotope imaging at the time of administration of intraperitoneal chemotherapy <br>;Secondary Objective: -Assess tolerance to treatment based on the diffusion<br> -Describe the sites of intraperitoneal relapse depending on the product distribution<br>;Primary end point(s): - Quantify and localise anomalies in the peritoneal cavity fixing<br>;Timepoint(s) of evaluation of this end point: the assessment will be realised during the chemotherapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Correlate the intensity of binding to the location of the pain in the peritoneal cavity<br> - Correlate the degree of pain intensity setting in the peritoneal cavity<br> - Correlate sites relapse localization uptake abnormalities in the peritoneal cavity<br>;Timepoint(s) of evaluation of this end point: the assessment will be realised during the chemotherapy and until 5 years after chemotherapy for the relapses