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
Categories (click each to see list of all clinical trials associated with that category): Gyn/Onc (OB/GYNONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Rodabaugh, Kerry
Contact Information:
Pamela Nielsen
pnielsen@nebraskamed.com
Eligibility: https://www.clinicaltrials.gov/study/NCT04095364?term=%09NCT04095364&rank=1
Summary
Primary Objective
1.1.1 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
1.2.1 To compare the nature, frequency and maximum degree of toxicity as assessed by CTCAE v5.0 for each treatment arm.
1.2.2 To compare the relative frequency of objective tumor response in those with measurable disease after cytoreductive surgery for each treatment arm.
1.2.3 To compare overall survival for each treatment arm.
1.2.4 To compare the CT\L and L\L arms with respect to patients adherence to letrozole therapy as measured by pill counts.