A Phase 3 Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus No HIPEC followed by Niraparib in People Newly Diagnosed With Advanced Ovarian Cancer

Share

Full Title

A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Hyperthermic Ovarian Treatment Trial) [WCG IRB]

Purpose

Hyperthermic intraperitoneal chemotherapy (HIPEC) involves giving heated chemotherapy directly into the belly immediately after surgery to remove an abdominal cancer. Researchers are doing this study to see if HIPEC improves outcomes in people with ovarian cancer. The people in this study have newly diagnosed stage 3 or 4 ovarian cancer.

If you join this study, you will be randomly assigned to get one of these treatments:

  • Presurgical chemotherapy followed by HIPEC with cisplatin during surgery, and then niraparib as maintenance therapy.
  • Presurgical chemotherapy without HIPEC during surgery, and then niraparib as maintenance therapy.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have high-grade stage 3 or 4 ovarian, primary peritoneal, or fallopian tube cancer that is newly diagnosed.
  • Have received or will get chemotherapy before surgery.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Dennis Chi’s office at 212-639-5016.

Protocol

24-278

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05659381