GOG-3068 HIPEC (Hyperthermic Ovarian Cancer Treatment) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if giving heated chemotherapy into the belly, a procedure known as heated intraperitoneal chemotherapy (HIPEC), can improve treatment results for patients with ovarian cancer.
What is the Condition Being Studied?
Stage III and IV Ovarian Cancer
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with stages III-IV ovarian cancer
- Have not received previous treatment for ovarian cancer with the exception of the first 3-4 cycles of platinum-based neoadjuvant chemotherapy
For more information about who can join this study, please contact the study team at 919-684-3780.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group of participants will receive neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery, and then receive HIPEC at the time of surgery.
- The other group will receive neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery followed by standard postoperative chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin.
Participants in both groups will then receive maintenance therapy with niraparib for up to 3 years.
Study Details
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)
Principal Investigator
Gynecologic Oncologist
Protocol Number
IRB:
PRO00114078
NCT:
NCT05659381
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Call 919-684-3780