| Trial ID # | NCT00426257; OVHIPEC-1 |
| Phase | III |
| Drug Class | Chemotherapy |
| Drug Name | HIPEC |
| Alternate Drug Names | Hyperthermic Intraperitoneal Chemotherapy |
| Drugs in Trial | Carboplatin, HIPEC, Paclitaxel |
| Eligible Participant | Stage III epithelial ovarian cancer with CR, PR or SD after 3 cycles of neoadjuvant carboplatin+paclitaxel |
| Patients Enrolled | 245 |
| Therapy Setting | First-line |
| Study Design | Open-Label, Randomized |
| Endpoints | RFS, OS, evaluated per RECIST or CA125 |
| Efficacy | CarboPt+Pac+HIPEC vs CarboPt+Pac+Placebo: RFS: 14.3 vs 10.7 months, HR: 0.63 (0.48-0.83, p=0.0008) Exploratory analysis, BRCA/HRD status: |
| Clinically Significant Adverse Events | CarboPt+Pac+HIPEC vs CarboPt+Pac+Placebo: |
| Conclusion | Among patients with stage III ovarian cancer, the addition of HIPEC to interval cytoreductive surgery resulted in longer RFS and OS than surgery alone and did not show higher rates of side effects |
| Reference | van Driel WJ et al. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med (2018) 18;378(3):230-240 Koole SN et al. Effect of HIPEC according to HRD/BRCAwt genomic profile in stage III ovarian cancer: Results from the phase III OVHIPEC trial. Int J Cancer (2022) 151(8):1394-1404 Lot Aronson S et al. Cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy in patients with advanced ovarian cancer (OVHIPEC-1): final survival analysis of a randomised, controlled, phase 3 trial. Lancet Oncol (2023) 24(10):1109-1118 |