A Phase II Study Of Tailored Adjuvant Therapy In Pole-Mutated And P53- Wildtype/NSMP Early-Stage Endometrial Cancer (Rainbow Blue & Taper)
Objective
Three groups of patients as below will be assessed separately for the following objectives: Sub-study A (RAINBO BLUE), Cohort A1: with early-stage POLE-mutated EC, Sub-study A (RAINBO BLUE), Cohort A2-Exploratory: with POLE-mutated EC where less data are available to define risk of recurrence and Sub-study B (TAPER): with p53wt/NSMP ER+ EC
Primary Objective: 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: 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.
