NRG-GY019

Closed to Accrual

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Protocol Information

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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

Status

Closed to Accrual

Open to Accrual

August 26, 2019

Closed to Accrual

May 9, 2025


Disease Site

Gynecologic [GY] Ovarian

Phase

III

Developmental Therapeutics

No

Primary Objective

To examine if letrozole monotherapy/maintenance is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Patient Population

Women with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum after primary surgical cytoreduction.

Target Accrual

450

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.