RecruitingEndometrial Cancer

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

Eligible age

18+ yrs

Accepts

Women

Locations

28 states

Healthy volunteers

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About this study

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

Sponsor: Canadian Cancer Trials Group

You may qualify if…

✓ 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.
✓ 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

You may not qualify if…

✕ 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)
✕ Patients with a documented positive surgical margin.
✕ Patients with a documented positive peritoneal washings, if performed.