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
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.
Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
Prior pelvic radiation.
Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Canadian Cancer Trials Group
Lead sponsor
Canadian Cancer Clinical Trials Network
Collaborator
Australia New Zealand Gynaecological Oncology Group
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Leiden University Medical Center
Collaborator
Mario Negri Gynecologic Oncology group (MaNGO)
Collaborator
NRG Oncology
Collaborator
Philipps University Marburg
Collaborator