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

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

Trial Details

NCT ID
NCT05640999
Phase
PHASE2
Sponsor
Canadian Cancer Trials Group
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Vaginal brachytherapy
  • Adjuvant radiotherapy (EBRT +/- brachytherapy)
  • Observation
Locations (sample)
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Los Angeles, California, United States|34.05223,-118.24368
  • Pasadena, California, United States|34.14778,-118.14452
  • Sacramento, California, United States|38.58157,-121.4944

Key Eligibility Criteria

  • Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per instit…
  • Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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