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NRG-GY019

Trial

Clinical Trial Title

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

Trial Status

Open to Enrollment

Start Date

December 18, 2019

Trial Type

Cancer - Adult Oncology

Specific Condition

Ovarian Cancer

Description

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary or peritoneum compared to paclitaxel and carboplatin without letrozole.

Eligibility Criteria

Eligibility Criteria

  • Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal or suboptimal residual disease status allowed.
  • Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:51 PM