Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT04811703
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years and ≤ 75 years
* ECOG PS 0-2 ;
* Epithelial stage IIb to IVa carcinoma of the ovary, fallopian tubes, or peritoneum proven histologically, stage III or IV of the FIGO classification and with history of insufficient tumor response/ after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy as judged by the investigators after discussion and validation in Multidisciplinary Team ;
* Adequate hematologic function
* Absolute Neutrophil Count \> 1500 / mm3 (or 1.5 10 9/L)
* Hemoglobin ≥ 9.0 g/dL,
* platelets \> 100 G/L,
* Adequate hepatic and renal function:
* Serum creatinine ≤1.5 times upper normal values or glomerular filtration rate ≥ 60 mL/min/1.73 m2 estimated by the CKD-EPI equation
* Total bilirubin ≤1.5 times the upper normal limit,
* ASAT / ALAT ≤1.5 times the upper normal limit (≤5 times upper normal limits for patients with liver metastases);
* Absence of unstable pathologies : myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric disorders, severe infection, peptic ulcer, or any pathology that could be aggravated by treatment or limit compliance (investigator's judgment)
* Patient information given and Written informed consent obtained prior to the initiation of any specific study procedure
* Affiliated to a social insurance regime or similar
Exclusion Criteria:
* Extra-peritoneal metastases (position or number which make the disease unresectable)
* Signs of intestinal obstruction or lesions with risk of intestinal perforation, or signs of inflammatory disease of the digestive tract
* Contraindication to systemic chemotherapy CARBOPLATIN-PACLITAXEL :known allergy to paclitaxel
* Contraindication to the PIPAC procedure:
* Known allergy to cisplatin or other platinum-containing compounds
* Known allergy to doxorubicin or other anthracyclines or anthracenediones;
* Heart failure with myocardial insufficiency
* Uncontrolled coronary insufficiency;
* Pregnancy or breastfeeding
* Persons deprived of liberty or under guardianship ;
* Major patient protected by the Law;
* Persons participating in other research with an exclusion period still in progress at the time of inclusion or research that may interfere with the results of the present study (investigator's judgment) ;
* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychic reasons (investigator's judgement)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04811703
Study Brief:
Protocol Section:
NCT04811703