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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

Protocol: NRG – GY019

SCHEMA NRG-GY019

Please Note: Below is only a brief description of eligibility, please contact the Genesys Hurley Cancer Institute, Research Department at (810)762-8181, (810)762-8079 or (810)762-8038 to discuss the full eligibility requirements

Eligibility:

  1. Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers. NOTE: Patients with a prior history of serous borderline tumors but a new diagnosis of Stage II-IV low-grade serous ovarian cancer are eligible.
  2. Age ≥ 18.
  3. Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (<=1cm diameter residual disease/nodule) or suboptimal residual disease
    (>1 cm diameter residual disease/nodule) status allowed.
  4. Patients must have undergone a bilateral salpingo-oophorectomy.
  5. Patients must have an ECOG Performance Status of 0, 1 or 2.
  6. Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.
  7. 1 Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Ineligibility:

  1. Patients may not have received neoadjuvant or adjuvant chemotherapy or radiotherapy for the treatment of this disease.
  2. Patients may not have received previous hormonal therapy for the treatment of this disease.