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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

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. Secondary Objectives To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm. To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm. To compare overall survival for each treatment arm. To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.



Recruitment Status

Past Studies