Status:
RECRUITING
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Collaborating Sponsors:
Direction Générale de l'Offre de Soins
Conditions:
Ovarian Cancer
Intraperitoneal Chemotherapy
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Clinicians postulate that it may be interesting to combine the two IntraPeritoneal (IP) treatments associated with a significant improvement of OC overall survival i.e. cytoreductive surgery with hype...
Detailed Description
Epithelial ovarian cancer (EOC) is the main cause of gynecological cancer death in developed countries, reflecting a clinical diagnosis possible at an advanced-stage of the disease and an early propen...
Eligibility Criteria
Inclusion
- 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 (measured on a thoracic CT scanner, the largest thickness of which is less than 3 cm),
- 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.
Exclusion
- Performance Index (WHO) ≥ 2,
- Stage IV B or IV A with significant pleural effusion (measured on a thoracic CT scanner, the largest thickness of which is more than 3 cm),
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04282356
Start Date
September 15 2020
End Date
December 1 2030
Last Update
February 12 2025
Active Locations (1)
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1
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, France, 34298