Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC v8 Clinical Trial
Official title:
A Phase II Study of Tailored Adjuvant Therapy in Pole-Mutated and p53-Wildtype/NSMP Early-Stage Endometrial Cancer (RAINBO BLUE &Amp; TAPER)
This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.
PRIMARY OBJECTIVE: I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status. SECONDARY OBJECTIVES: I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years. II. Estimate the recurrence-free, endometrial cancer-specific and overall survival. III. Describe the impact of molecular classification on patient decisional conflict and fear of recurrence. TERTIARY OBJECTIVES: I. Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer. II. Evaluate quality of life. III. 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. IV. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/no specific molecular profile (NSMP) endometrial cancer (EC). OUTLINE: Patients are assigned to 1 of 2 sub-studies. SUB-STUDY A: Patients are assigned to 1 of 2 cohorts. COHORT A1: Patients with POLE-mutated early-stage EC undergo observation on study. COHORT A2: Patients with higher-risk POLE-mutated EC undergo observation or external beam radiation therapy (EBRT) and/or vaginal brachytherapy over 3-5 fractions. SUB-STUDY B: Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. All patients undergo chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans during screening and as clinically indicated throughout the trial. After completion of study treatment, patients are followed up at 3 and 6 months, then every 6 months for 3 years, and then every year. ;