This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies * EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC
This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer. The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
393
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.
Observation
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
Time frame: 3 years
Estimate the rate of isolated vaginal recurrence at 3 years
Time frame: 3 years
Estimate the rate of para-aortic recurrence at 3 years
Time frame: 3 years
Estimate the rate of distant metastasis at 3 years
Time frame: 3 years
Estimate recurrence-free survival
Time frame: 9 years
Estimate endometrial cancer-specific survival
Time frame: 9 years
Estimate overall survival
Time frame: 9 years
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Time frame: 9 years
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