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Clinical Trials in France / NCT04282356
Recruiting Phase 2

Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer

NCT04282356 · tracked via the Priya Life Science France tracker
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Phase
Phase 2
Started
2020-09-15
Last updated
2025-02-12

Condition(s) studied

Ovarian CancerIntraperitoneal Chemotherapy

Investigational drug(s) / intervention(s)

Intraperitoneal chemotherapy during surgery

Intraperitoneal chemotherapy during surgery: During interval surgery the patient will undergo HIPEC (Cisplatin 100mg/m2, 1h 30 infusions with sodium thiosulfate renal protection). They will then receive postoperative IPC i.e intravenous and intraperitoneal administration (IV Paclitaxel, 135mg/m2 on D1, IP Carboplatin, AUC 6 on D1, and IP Paclitaxel, 60mg/m2 on D8) with at least 3 courses performed (up to 4-6 allowed).

Study 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 hyperthermic intraperitoneal chemotherapy (HIPEC) and postoperative intraperitoneal chemotherapy (IPC) as an " intensive peritoneal " regimen in the initial management of stages III-IVA ovarian cancers. Performing a postoperative IPC may allow completing and extending the duration of the effect of HIPEC in decreasing the risk of peritoneal recurrence. HIPEC may also allow administering an early IP treatment on the residual microscopic disease during initial or interval surgery with an optimal access to the intraperitoneal cavity. Postoperative IPC will extend the HIPEC effect on unsterilized peritoneal microscopic residues with the aim of decreasing the risk of local recurrence. Performing HIPEC before IPC could allow limiting the number of postoperative IP courses needed. Nevertheless, this association questions its feasibility and tolerance, which should both be assessed in a phase II trial. Clinicians propose to conduct this feasibility study combining for the first time HIPEC with IPC as first-line treatment of ovarian cancer with peritoneal carcinomatosis to perform a peritoneal intensification.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The success of the combination of HIPEC and IPC assessed by chemotherapy administration after surgery — Until the chemotherapy courses completion: 6 months after interval surgery
    Number of administred courses of intraperitoneal chemotherapy during the 6 months following complete interval cytoreductive surgery with HIPEC.
  • The success of HIPEC and IPC combination assessed by surveillance safety — Until the chemotherapy courses completion: 6 months after interval surgery
    Rate of HIPEC tolerance (deterioration of the renal function and morbidity of HIVEC) and CIP tolerance (abdomibal pain and complications of the IP treatment)

Trial sites (1)

FacilityCityRegionStatus
Institut du Cancer de Montpellier - Val d'Aurelle Montpellier France Recruiting

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Other trials for the same condition

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Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Active, not recruiting
A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer Recruiting
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Active, not recruiting
A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous (IV) ABBV901 Moves Through the Body Alone or in Combination With Other Anticancer Drugs in Adult Participants With Ovarian Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04282356 on ClinicalTrials.gov ↗ ← All trials in France