Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria: 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. Patients' age must be ≥ 18 years. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy Exclusion Criteria: Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis. Prior pelvic radiation. Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid 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) (
Sites / Locations
- Cross Cancer InstituteRecruiting
- BCCA - Vancouver Cancer CentreRecruiting
- BCCA - Vancouver Island Cancer CentreRecruiting
- London Regional Cancer ProgramRecruiting
- Trillium Health Partners - Credit Valley HospitalRecruiting
- University Health NetworkRecruiting
- Leiden University Medical Center (LUMC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Sub-study A: RAINBO BLUE Cohort A1
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Sub-Study B: TAPER
Observation
Observation or Adjuvant Radiotherapy
Observation or Vaginal Brachytherapy