Clinical Trial

Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Active, Not Recruiting Phase 3
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Summary
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, fallopian tube, 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, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2019-09-18; most recent amendment 2026-03-23.
Status change: Recruiting → Active, Not Recruiting 2025-05-15
Trial Details
NCT Number NCT04095364
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Low Grade Fallopian Tube Serous Adenocarcinoma, Ovarian Low Grade Serous Adenocarcinoma, Primary Peritoneal Low Grade Serous Adenocarcinoma, Stage II Fallopian Tube Cancer AJCC v8, Stage II Ovarian Cancer AJCC v8, Stage II Primary Peritoneal Cancer AJCC v8, Stage III Fallopian Tube Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8 +4 more
Enrollment 450 participants
Start Date 2019-09-20
Primary Completion 2027-02-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-24