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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: Recruiting
We are looking at 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 and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
Exclusion Criteria:
• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Interventions:
Procedure: Biopsy, Procedure: Biospecimen Collection, Drug: Carboplatin, Procedure: Imaging Technique, Drug: Letrozole, Drug: Paclitaxel
Conditions:
Cancer
Keywords:
Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma
Study Contact: Kristen Nelson - knelso65@fairview.org
Principal Investigator: Rahel Ghebre, Dr
Phase: PHASE3
IRB Number: MMCORC048
See this study on ClinicalTrials.gov