OncoMatch/Clinical Trials/NCT04282356
Intensive Intraperitoneal Therapy in Advanced Ovarian Cancer
Is NCT04282356 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Intraperitoneal chemotherapy during surgery for ovarian cancer.
Treatment: Intraperitoneal chemotherapy during surgery — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Required: Stage IIIB, IIIC, IVA (FIGO 2014)
Excluded: Stage IVB
Metastatic disease required
Grade: high gradegrade IIgrade III (MD Anderson, Silverman)
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)
Performance status
WHO 0–1
Prior therapy
Must have received: neoadjuvant chemotherapy (carboplatin, paclitaxel) — neoadjuvant
Indication of 3 to 4 cures of neoadjuvant chemotherapy based on the Carboplatin-Paclitaxel (carbo-taxol) combination
Cannot have received: chemo-hyperthermia
Patient who has already been treated with chemo-hyperthermia for ovarian cancer
Lab requirements
Blood counts
hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 10^9 / L, platelets ≥ 100 x 10^9 / L
Kidney function
Absence of renal insufficiency (creatinine clearance ≤ 70 ml / min) according to the MDRD method
Liver function
Total bilirubin ≤ 1.5 LSN, ALT or AST ≤ 3 ULN
Hematologic function, hemoglobin ≥ 10 g / dl; PNN ≥ 1 x 10^9 / L, platelets ≥ 100 x 10^9 / 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
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