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Title:
GY019 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
Protocol Number:
NCTNGY019
Phase:
Phase III
Physician:
Amanda Nickles Fader
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to compare the treatment of carboplatin/paclitaxel and letrozole hormonal therapy to letrozole alone.
Eligibility:
Women with low-grade serous carcinoma of the ovary or peritoneum may be eligible to participate.
Treatment:
If you decide to take part in this study, you will get either the combination of paclitaxel and carboplatin for four and a half months followed by letrozole or letrozole alone, as long as you are tolerating the letrozole drug (i.e., have not developed any allergies or severe side effects with the medication) and have not experienced a recurrence or progression of your disease. After you finish your study treatment, your doctor and study team will continue to follow your condition and watch you for side effects during clinic visits or by phone if you are unable to visit the clinic. They will check you every 3 months for the first 3 years after treatment. After that, they will check you every 6 months for two years. This means you will keep seeing your doctor for up to 5 years after treatment.
Population:
Adult
Last Update
08/11/2020 05:02 AM