Phase III Randomised Clinical Trial for Stage III Ovarian Carcinoma Randomising Between Secondary Debulking Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Trial ID # NCT00426257; M06OVH-OVHIPEC
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: 14.2 vs 10.7 months, HR: 0.66 (0.50-0.87, p=0.003)
OS: 45.7 vs 33.9 months, HR: 0.67 (0.48-0.94, p=0.02)

Clinically Significant Adverse Events

CarboPt+Pac+HIPEC vs CarboPt+Pac+Placebo:
Serious AE:
Grade 3-4 AE: overall (27 vs 25%)

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
https://pubmed.ncbi.nlm.nih.gov/29342393/

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