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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with stages III-IV ovarian cancer</li>
<li>Have not received previous treatment for ovarian cancer with the exception of the first 3-4 cycles of platinum-based neoadjuvant chemotherapy</li></ul>
For more information about who can join this study, please contact the study team at 919-684-3780.
<li>Are diagnosed with stages III-IV ovarian cancer</li>
<li>Have not received previous treatment for ovarian cancer with the exception of the first 3-4 cycles of platinum-based neoadjuvant chemotherapy</li></ul>
For more information about who can join this study, please contact the study team at 919-684-3780.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
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:<ul>
<li>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.</li>
<li>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.</li></ul>
Participants in both groups will then receive maintenance therapy with niraparib for up to 3 years.
<li>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.</li>
<li>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.</li></ul>
Participants in both groups will then receive maintenance therapy with niraparib for up to 3 years.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Jennifer
McNally
Protocol Number
PRO00114078
NCT ID
NCT05659381
Phase
III
Enrollment Status
Open to Enrollment