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

RecruitingPhase 2

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

Who can join

Ages 18 and older · Women

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.

About the 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

What is being tested

Sponsor: Canadian Cancer Trials Group · Participants: 393 · Started: Dec 19, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05640999

Locations in the U.S.

AlaskaAlaska Womens Cancer Care, Anchorage
ArizonaUniversity of Arizona Cancer Center, Tucson
CaliforniaCedars-Sinai Medical Center, Los Angeles
Huntington Memorial Hospital, Pasadena
Sutter Medical Center Sacramento, Sacramento
ColoradoUCHealth University of Colorado Hospital, Aurora
AdventHealth Porter, Denver
FloridaUM Sylvester Comprehensive Cancer Center at, Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral, Doral
University of Florida, Gainesville
University of Miami School of Medicine, Miami
Sarasota Memorial Hospital - Venice, N. Venice
University of Miami Sylvester, North Miami
UM Sylvester Comprehensive Cancer Center, Plantation
First Physicians Group-Sarasota, Sarasota
Florida Cancer Specialists - Sarasota Downtown, Sarasota
Sarasota Memorial Health Care Centre, Sarasota
Sarasota Memorial Hospital, Sarasota
Florida Cancer Specialists - Venice Pinebrook, Venice
GeorgiaEmory Saint Josephs Hospital, Atlanta
Emory University Hospital Midtown, Atlanta
Emory University Hospital Winship Cancer Institute, Atlanta
Grady Health System, Atlanta
Piedmont Hospital, Atlanta
Emory Decatur Hospital, Decatur
IllinoisNorthwestern University, Chicago
Northwestern Medicine Orland Park, Orland Park
Northwestern Medicine Cancer Center Warrenville, Warrenville
IndianaAscension Saint Vincent Indianapolis Hospital, Indianapolis
KentuckyNorton Hospital Pavilion and Medical Campus, Louisville
Norton Suburban Hospital and Medical Campus, Louisville
LouisianaUniversity Medical Center New Orleans, New Orleans
MassachusettsMassachusetts General Hospital Cancer Center, Boston
Baystate Medical Center, Springfield
UMass Memorial Medical Centre, Worcester
MinnesotaMercy Hospital, Coon Rapids
MissouriWashington University School of Medicine, St Louis
NebraskaNebraska Methodist Hospital, Omaha
NevadaWomens Cancer Center of Nevada, Las Vegas
New JerseySidney Kimmel Cancer Center Washington Township, Sewell
New YorkRoswell Park Cancer Institute, Buffalo
Mount Sinai Chelsea, New York
Mount Sinai Hospital, New York
Upstate Cancer Center Radiation Oncology at Oswego, Oswego
State University of New York, Syracuse
Upstate Cancer Center at Hill Radiation Oncology, Syracuse
Upstate Cancer Center at Verona, Verona
North CarolinaUNC Lineberger Comprehensive Cancer Center, Chapel Hill
Duke University Medical Center, Durham
Duke Womens Cancer Care Raleigh, Raleigh
OhioUHHS-Chagrin Highlands Medical Center, Beachwood
Geauga Hospital, Chardon
Case Western Reserve University, Cleveland
Ohio State University Comprehensive, Columbus
UH Seidman Cancer Center, Mentor
University Hospitals Parma Medical Center, Parma
UH Seidman Cancer Center, Westlake
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
OregonProvidence Portland Medical Centre, Portland
Providence Saint Vincent Medical Center, Portland
PennsylvaniaPenn State Milton S Hershey Medical Center, Hershey
Paoli Memorial Hospital, Paoli
Thomas Jefferson University, Philadelphia
Asplundh Cancer Pavilion, Willow Grove
Lankenau Medical Center, Wynnewood
Rhode IslandWomen and Infants Hospital, Providence
TexasM.D. Anderson Cancer Center, Houston
UtahFarmington Health Centre, Farmington
Huntsman Cancer Institute University of Utah, Salt Lake City
University of Utah Sugarhouse Health Centre, Salt Lake City
VermontUniversity of Vermont Medical Center, Burlington
University of Vermont and State Agricultural College, Burlington
VirginiaUniversity of Virginia Cancer Center, Charlottesville
Virginia Commonwealth University, Richmond
WashingtonSwedish Medical Center First Hill, Seattle
WisconsinSaint Vincent Hospital Cancer Center Green Bay, Green Bay
Medical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.