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

RecruitingPhase 2Ages 18 Years - anyFemaleCanadian Cancer Trials Group
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients' age must be โ‰ฅ 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: 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 โ‰ฅ 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.
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What it tests

  • Vaginal brachytherapy
  • Adjuvant radiotherapy (EBRT +/- brachytherapy)
  • Observation
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Where

123 sites
Alaska Womens Cancer Care
Anchorage, United States
University of Arizona Cancer Center
Tucson, United States
Cedars-Sinai Medical Center
Los Angeles, United States
Huntington Memorial Hospital
Pasadena, United States
Sutter Medical Center Sacramento
Sacramento, United States
UCHealth University of Colorado Hospital
Aurora, United States
AdventHealth Porter
Denver, United States
UM Sylvester Comprehensive Cancer Center at
Deerfield Beach, United States

โ€ฆand 115 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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