NCT05640999From ClinicalTrials.govRecruiting

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

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

Endometrial Cancer

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Canadian Cancer Trials Group
Enrolment target: 393
Started: 19 December 2022
Main results due: 31 December 2028
Study sites: 122
Registry updated: 24 September 2026

Can you take part?

Aged 18 years and over.
Women only.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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 ≥ 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 ≥ 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.

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(122)

Alaska Womens Cancer Care
Anchorage, Alaska, United States
Recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Huntington Memorial Hospital
Pasadena, California, United States
Recruiting
Sutter Medical Center Sacramento
Sacramento, California, United States
Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Recruiting
AdventHealth Porter
Denver, Colorado, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at
Deerfield Beach, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, United States
Recruiting
University of Florida
Gainesville, Florida, United States
Recruiting
University of Miami School of Medicine
Miami, Florida, United States
Recruiting
Sarasota Memorial Hospital - Venice
N. Venice, Florida, United States
Recruiting
University of Miami Sylvester
North Miami, Florida, United States
Recruiting
UM Sylvester Comprehensive Cancer Center
Plantation, Florida, United States
Recruiting
Florida Cancer Specialists - Sarasota Downtown
Sarasota, Florida, United States
Recruiting
First Physicians Group-Sarasota
Sarasota, Florida, United States
Recruiting
Sarasota Memorial Hospital
Sarasota, Florida, United States
Recruiting
Sarasota Memorial Health Care Centre
Sarasota, Florida, United States
Recruiting
Florida Cancer Specialists - Venice Pinebrook
Venice, Florida, United States
Recruiting
Grady Health System
Atlanta, Georgia, United States
Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, United States
Recruiting
Piedmont Hospital
Atlanta, Georgia, United States
Recruiting
Emory University Hospital Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Emory Saint Josephs Hospital
Atlanta, Georgia, United States
Recruiting
Emory Decatur Hospital
Decatur, Georgia, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, United States
Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Recruiting
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Recruiting
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States
Recruiting
Norton Suburban Hospital and Medical Campus
Louisville, Kentucky, United States
Recruiting
University Medical Center New Orleans
New Orleans, Louisiana, United States
Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Recruiting
Baystate Medical Center
Springfield, Massachusetts, United States
Recruiting
UMass Memorial Medical Centre
Worcester, Massachusetts, United States
Recruiting
Mercy Hospital
Coon Rapids, Minnesota, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Recruiting
Womens Cancer Center of Nevada
Las Vegas, Nevada, United States
Recruiting
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Recruiting
Mount Sinai Chelsea
New York, New York, United States
Recruiting
Mount Sinai Hospital
New York, New York, United States
Recruiting
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, United States
Recruiting
State University of New York
Syracuse, New York, United States
Recruiting
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, United States
Recruiting
Upstate Cancer Center at Verona
Verona, New York, United States
Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Duke Womens Cancer Care Raleigh
Raleigh, North Carolina, United States
Recruiting
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, United States
Recruiting
Geauga Hospital
Chardon, Ohio, United States
Recruiting
Case Western Reserve University
Cleveland, Ohio, United States
Recruiting
Ohio State University Comprehensive
Columbus, Ohio, United States
Recruiting
UH Seidman Cancer Center
Mentor, Ohio, United States
Recruiting
University Hospitals Parma Medical Center
Parma, Ohio, United States
Recruiting
UH Seidman Cancer Center
Westlake, Ohio, United States
Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Recruiting
Providence Portland Medical Centre
Portland, Oregon, United States
Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Recruiting

Showing 60 of 122 sites — filter to narrow it down. 122 of the 122 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05640999. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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