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

Recruiting now · Phase 2

Conditions studied: Endometrial Cancer

In brief

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

Key facts

Study ID

NCT05640999

Run by

Canadian Cancer Trials Group

People needed

393

Starts

2022-12-19

Expected to finish

2029-06-30

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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
• Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

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.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Huntington Memorial Hospital — Pasadena, California, United States (enrolling)
• Sutter Medical Center Sacramento — Sacramento, California, United States (enrolling)
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• AdventHealth Porter — Denver, Colorado, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• University of Miami School of Medicine — Miami, Florida, United States (enrolling)
• Sarasota Memorial Hospital - Venice — N. Venice, Florida, United States (enrolling)
• Florida Cancer Specialists - Sarasota Downtown — Sarasota, Florida, United States (enrolling)
• First Physicians Group-Sarasota — Sarasota, Florida, United States (enrolling)
• Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
• Sarasota Memorial Health Care Centre — Sarasota, Florida, United States (enrolling)
• Florida Cancer Specialists - Venice Pinebrook — Venice, Florida, United States (enrolling)
• Grady Health System — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Piedmont Hospital — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital Winship Cancer Institute — Atlanta, Georgia, United States (enrolling)
• Emory Saint Josephs Hospital — Atlanta, Georgia, United States (enrolling)
• Emory Decatur Hospital — Decatur, Georgia, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Northwestern Medicine Orland Park — Orland Park, Illinois, United States (enrolling)
• Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States (enrolling)
• Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States (enrolling)
• Alaska Womens Cancer Care — Anchorage, Alaska, United States (enrolling)

Full record on ClinicalTrials.gov

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