NCT05659381

Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer

GOG-3068: A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Homologous Recombinant Deficient (HRD +) Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: GOG Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).

Conditions

• Stage III Ovarian Cancer
• Stage IV Ovarian Cancer
• Stage III Primary Peritoneal Cancer
• Stage IV Primary Peritoneal Cancer
• Stage III Fallopian Tube Cancer
• Stage IV Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 100mg/m2 IP over 90 minutes at 42 degrees Celcius
OTHER	No treatment	No treatment with Cisplatin

Timeline

• Start date: 2024-03-08
• Primary completion: 2029-08-01
• Completion: 2034-08-01
• First posted: 2022-12-21
• Last updated: 2026-04-16

Locations

59 sites across 1 country: United States

Regulatory

• FDA-regulated drug study