NRG-GY019 (Ovarian or Peritoneum Cancer)
What is the 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.
What is the Condition Being Studied?
Cancer of the Ovary or Peritoneum
Who Can Participate in the Study?
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 Group
Adults
What is Involved?
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
You will have follow-up visits every 3 months for 3 years, and then every 6 months for 2 years.
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
Professor of Obstetrics and Gynecology
Protocol Number
IRB:
PRO00104152
NCT:
NCT04095364
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
Participate
Call 919-684-3780