NRG-GY019 - Clinical Trial

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:
- Be randomized (like flipping a coin) to Group 1 or Group 2
--Group one will take Paclitaxel and Carboplatin (standard chemotherapy drugs) folllowed by Letrozole (hormone therapy)
-- Group 2 will take only Letrozole
-Complete 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
Gynecologic Oncologist
Protocol Number
IRB: PRO00104152
NCT: NCT04095364
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698