Intensive intraperitoneal therapy in advanced ovarian cancer combining cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC).
- Conditions
- Patient with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003357-29-FR
- Lead Sponsor
- Institut Régional du Cancer de Montpellier (ICM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 55
-Patients aged 18 to 75 years,
-Patients with high-grade serous (high grade according to MD Anderson, grade II and III according to Silverman) ovarian or tubal or primitive peritoneal histologically proven cancer,
-Initial laparoscopy confirming the histological type, evaluating the extent of the disease by PCI score and confirming the initial non-resectability,
-Stage III B-C (FIGO 2014) or stage IVA with minimal or moderate pleural effusion,
-Complete interval cytoreduction surgery,
-Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination,
-The delay between the last course of NAT and the surgery must be between 4 and 8 weeks,
-Hematologic function, hemoglobin = 10 g / dl; PNN = 1 x 109 / L, platelets = 100 x 109 / L,
-Total bilirubin = 1.5 LSN, ALT or AST = 3 ULN,
-Absence of renal insufficiency (creatinine clearance = 70 ml / min) according to the MDRD method,
-Informed consent signed before any specific procedure under consideration,
-Patients affiliated to the French social security scheme or equivalent.
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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
-Performance Index (WHO) = 2,
-Stage IV B or IV A with significant pleural effusion,
-Renal impairment (clearance <70 ml / min) according to the MDRD method,
-General contraindication to the realization of a tumor reduction surgery or HIPEC (contraindication or history allergic reaction to any treatments components),
-Hepatic insufficiency (bilirubin > 1.5 x normal, ASAT & ALAT > 3 x upper limit of normal),
-Serious life-threatening co-existing condition at stake,
-Cardio-respiratory pathology indicating hyper hydration, to be implemented for HIPEC,
-Patient who has already been treated with chemo-hyperthermia for ovarian cancer,
-History of cancer, except basal cell carcinoma of the skin or carcinoma in situ of cervix having recurred within five years prior to entry into this trial,
-Any severe untreated infectious disease,
-Peripheral sensory neuropathy = grade 2 at the inclusion time,
-Patients whose regular follow-up is a priori impossible for psychological, family, social or geographical reasons,
-Pregnant and / or nursing women,
-Subjects under tutelage, curatorship or safeguard of justice.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method