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Back|NCT05640999Recruiting
Official Title

A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)

Phase
Phase 2
Sponsor
Canadian Cancer Trials Group
Enrollment
393
Timeline
Dec 2022 → Jun 2029
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

Eligibility Criteria

Inclusion Criteria

  • 1Patients 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.
  • 2Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
  • 3Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
  • 4HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • 5Patients' age must be ≥ 18 years.
  • 6Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
  • 7Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
  • 8Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
  • 9Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

Exclusion Criteria

  • 1Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
  • 2Prior pelvic radiation.
  • 3Patients 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.
  • 4Clinical 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)
  • 5Patients with a documented positive surgical margin.
  • 6Patients with a documented positive peritoneal washings, if performed.

Locations

91 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Jill Remick

404-778-1900

Emory University Hospital Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Jill Remick

404-778-1900

Emory Saint Josephs Hospital

Atlanta, Georgia 30342

Recruiting

Jill Remick

404-778-1900
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →