Title
NRG GY019
Host/Owner
Cancer Trials Ireland
Location(s)
St. James’s Hospital, Dublin (currently) Cork University Hospital, Cork (opening soon)
Eligibility
• Newly diagnosed, stage II-IV low-grade serous ovarian cancer. • nonaberrant p53 expression • Age >= 18 • Patients must have undergone an attempt at maximal upfront cytoreductive surgery • Patients must have both ovaries and fallopian tubes removed • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Full title of trial
NRG 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”.
Full criteria
- Newly diagnosed, stage II-IV low-grade serous ovarian cancer.
- p53 immunohistochemistry (IHC) is required and must show non-aberrant pattern (non-aberrant p53 expression is consistent with normal/wildtype TP53
- Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 14 days prior to registration;
- Radiographic tumour assessment within 28 days prior to registration.
- Age >= 18
- Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (=< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed
- Patients must have undergone a bilateral salpingo-oophorectomy
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration
- Patients must be within =< 8 weeks of primary cytoreductive surgery at time of randomization
- 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.
Open & close dates
Opened in St. James’s Hospital March 2024.
Opening soon in Cork University Hospital.
Expected Last Patient In September 2025.
Who to contact
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
