Purpose of this Study
We are doing this study to learn if taking Paclitaxel and Carboplatin, folllowed by Letrozole or taking Letrozole alone is best to lower the chance of ovarian or peritoneal cancer spreading.
Who Can Participate?
Eligibility
Adults with cancer of the ovary or peritoneum who are newly diagnosed with Stage II-IV low-grade serous ovarian cancer, fallopian tube, and primary peritoneal cancers.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like flipping a coin) to Group 1 or Group 2:
- Group 1 will take Paclitaxel and Carboplatin (standard chemotherapy drugs) folllowed by Letrozole (hormone therapy)
- Group 2 will take only Letrozole
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
NRG-GY019: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
Principal Investigator
Angeles
Secord
Protocol Number
PRO00104152
NCT ID
NCT04095364
Phase
III
Enrollment Status
Open to Enrollment