peritoneal carcinomatosis of ovarian origin
Conditions
Interventions
Trade Name: Nanocis, trousse pour la préparation de la solution injectable de sulfure de rhénium colloidal et de technetium (nanocolloide)
Pharmaceutical Form: Solution for infusion
Sponsors
Centre Jean Perrin
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -Evaluate the anatomical distribution of the isotope imaging at the time of administration of intraperitoneal chemotherapy ;Secondary Objective: -Assess tolerance to treatment based on the diffusion -Describe the sites of intraperitoneal relapse depending on the product distribution ;Primary end point(s): - Quantify and localise anomalies in the peritoneal cavity fixing ;Timepoint(s) of evaluation of this end point: the assessment will be realised during the chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Correlate the intensity of binding to the location of the pain in the peritoneal cavity - Correlate the degree of pain intensity setting in the peritoneal cavity - Correlate sites relapse localization uptake abnormalities in the peritoneal cavity ;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 | — |
Countries
France
Contacts
Public ContactClinical Trial Informations
Centre Jean Perrin
Outcome results
None listed