What is the Purpose of this Study?
Primary Objective Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumor molecular status. Secondary Objectives Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years. Estimate the recurrence-free, endometrial cancer-specific and overall survival. Describe the impact of molecular classification on patient s fear of recurrence. Tertiary Objectives Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer. Evaluate quality of life. Determine if variability in adjuvant treatment given to patients with endometrial cancer is decreased by molecular classification-tailored adjuvant therapy as compared to recent clinical practice data. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/NSMP EC.
Eligibility
- * Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
- * Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
- * Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
- * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Garrett Crook
More about this Clinical Trial
What is the full name of this clinical trial?
NRG-GY032: A Phase II Study of Tailored Adjuvant Therapy in Pole-mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer