Phase
Condition
Fallopian Tube Cancer
Abdominal Cancer
Malignant Ascites
Treatment
Combined PIPAC / IV chemotherapy treatment
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years and ≤ 75 years
ECOG PS 0-2 ;
Epithelial stage IIb to IVa carcinoma of the ovary, fallopian tubes, or peritoneumproven histologically, stage III or IV of the FIGO classification and with historyof insufficient tumor response/ after three cycles of previous neoadjuvant systemiccarboplatin-paclitaxel chemotherapy as judged by the investigators after discussionand 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 ≥ 60mL/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 forpatients with liver metastases);
Absence of unstable pathologies : myocardial infarction within 6 months prior to thestart of the study, congestive heart failure, unstable angina, activecardiomyopathy, unstable rhythm disorder, uncontrolled hypertension, uncontrolledpsychiatric disorders, severe infection, peptic ulcer, or any pathology that couldbe aggravated by treatment or limit compliance (investigator's judgment)
Patient information given and Written informed consent obtained prior to theinitiation of any specific study procedure
Affiliated to a social insurance regime or similar
Exclusion
Exclusion Criteria:
Extra-peritoneal metastases (position or number which make the disease unresectable)
Signs of intestinal obstruction or lesions with risk of intestinal perforation, orsigns of inflammatory disease of the digestive tract
Contraindication to systemic chemotherapy CARBOPLATIN-PACLITAXEL :known allergy topaclitaxel
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 progressat the time of inclusion or research that may interfere with the results of thepresent study (investigator's judgment) ;
Impossibility to submit to the medical follow-up of the trial for geographical,social or psychic reasons (investigator's judgement)
Study Design
Connect with a study center
Hôpital Claude Huriez - Chirurgie générale et digestive
Lille,
FranceActive - Recruiting
Hôpital Claude Huriez - Oncologie médicale
Lille,
FranceActive - Recruiting
Hôpital de la Croix-Rousse
Lyon,
FranceActive - Recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
FranceActive - Recruiting
Hôpital Lyon Sud - Chirurgie Digestive et Oncologique
Pierre-Bénite, 69495
FranceActive - Recruiting
Hôpital Lyon Sud - Chirurgie Gynécologique et oncologique-obstétrique
Pierre-Bénite,
FranceActive - Recruiting
Hôpital Lyon Sud - Oncologie Médicale
Pierre-Bénite,
FranceActive - Recruiting
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