Intensive treatment for advanced ovarian cancer using intraperitoneal therapy
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer Combining Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Postoperative Intraperitoneal Chemotherapy (IPC)
This study tests a new treatment for advanced ovarian cancer that combines surgery with special chemotherapy delivered directly into the abdomen to see if it helps patients live longer and reduces the chance of the cancer coming back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04282356 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the combination of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) followed by postoperative intraperitoneal chemotherapy (IPC) for patients with advanced stages III-IVA ovarian cancer. The approach aims to enhance overall survival by reducing the risk of peritoneal recurrence through intensive peritoneal treatment. Patients will undergo initial surgery followed by a regimen of intraperitoneal chemotherapy to target residual microscopic disease. The study evaluates the efficacy and safety of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 to 75 with high-grade serous ovarian cancer who are undergoing interval cytoreductive surgery.
Not a fit: Patients with non-serous ovarian cancer or those who are not eligible for cytoreductive surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and reduce recurrence in patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with intraperitoneal chemotherapy, indicating potential for success with this intensive approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Montpellier
- Institut du Cancer de Montpellier - Val d'Aurelle — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Aurore MOUSSION
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 0467613102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.