Could less be more? new trial tailors endometrial cancer treatment to tumor type

NCT ID NCT05640999

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 9 times

Summary

This phase II study is testing whether women with certain types of early-stage endometrial cancer can safely receive less aggressive treatment after surgery. The approach is guided by the tumor's molecular profile—either POLE-mutated or p53 wildtype/NSMP. Around 393 participants will receive either vaginal brachytherapy, external beam radiation, or simply observation, depending on their tumor type. The goal is to see if this personalized, de-escalated approach keeps pelvic recurrence rates low while avoiding unnecessary side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: radiation therapy (vaginal brachytherapy or external beam radiotherapy) or observation
What this could lead to: If successful, this could show that many patients with certain molecular subtypes of early endometrial cancer can safely receive less intensive treatment, reducing side effects while maintaining low recurrence rates.
What could go wrong: This is a phase II trial with a moderate sample size, so results may not be definitive. The de-escalated approach might lead to higher recurrence rates than standard therapy, and long-term outcomes are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 393 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm stage I endometrioid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

121 sites in 9 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

ASST Lecco
RECRUITING

Lecco, 23900, Italy
ASST Spedali Civili Brescia
RECRUITING

Brescia, 25123, Italy
AdventHealth Porter
RECRUITING

Denver, Colorado, 80210, United States
Alaska Womens Cancer Care
RECRUITING

Anchorage, Alaska, 99508, United States
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING

Calgary, Alberta, T2N 5G2, Canada
Ascension Saint Vincent Indianapolis Hospital
RECRUITING

Indianapolis, Indiana, 46260, United States
Asplundh Cancer Pavilion
RECRUITING

Willow Grove, Pennsylvania, 19090, United States
Auckland City Hospital
RECRUITING

Auckland, 1023, New Zealand
BCCA - Kelowna
RECRUITING

Kelowna, British Columbia, V1Y 5L3, Canada
BCCA - Prince George
RECRUITING

Prince George, British Columbia, V2M 7E9, Canada
BCCA - Vancouver
RECRUITING

Vancouver, British Columbia, V5Z 4E6, Canada
BCCA - Victoria
RECRUITING

Victoria, British Columbia, V8R 6V5, Canada
Baystate Medical Center
RECRUITING

Springfield, Massachusetts, 01199, United States
CHUM-Centre Hospitalier de l'Universite de Montreal
RECRUITING

Montreal, Quebec, H2X 3E4, Canada
CIUSSS de l'Estrie - Centre hospitalier
RECRUITING

Sherbrooke, Quebec, J1H 5N4, Canada
Calvary Mater Newcastle Hospital
RECRUITING

Waratah, New South Wales, 2298, Australia
Canberra Hospital
RECRUITING

Garran, ACT 2605, Australia
Case Western Reserve University
RECRUITING

Cleveland, Ohio, 44106, United States
Catharina ziekenhuis
RECRUITING

Eindhoven, North Brabant, 5623 EJ, Netherlands
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Centre Leon Berard
RECRUITING

Lyon, Auvergne-Rhône-Alpes, 69008, France
Christchurch Hospital
RECRUITING

Christchurch, 8140, New Zealand
Cross Cancer Institute
RECRUITING

Edmonton, Alberta, T6G 1Z2, Canada
Diak Klinikum Landkreis Schwaebisch Hall
RECRUITING

Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
Duke Womens Cancer Care Raleigh
RECRUITING

Raleigh, North Carolina, 27607, United States
Emory Decatur Hospital
RECRUITING

Decatur, Georgia, 30033, United States
Emory Saint Josephs Hospital
RECRUITING

Atlanta, Georgia, 30342, United States
Emory University Hospital Midtown
RECRUITING

Atlanta, Georgia, 30308, United States
Emory University Hospital Winship Cancer Institute
RECRUITING

Atlanta, Georgia, 30322, United States
Erasmus Medical Center (EMC)
RECRUITING

Rotterdam, Netherlands
European Institute of Oncology
RECRUITING

Milan, 20141, Italy
Farmington Health Centre
RECRUITING

Farmington, Utah, 84025, United States
First Physicians Group-Sarasota
RECRUITING

Sarasota, Florida, 34239, United States
Florida Cancer Specialists - Sarasota Downtown
RECRUITING

Sarasota, Florida, 34236, United States
Florida Cancer Specialists - Venice Pinebrook
RECRUITING

Venice, Florida, 34275, United States
Frankston Hospital
RECRUITING

Frankston, Victoria, 3199, Australia
Geauga Hospital
RECRUITING

Chardon, Ohio, 44024, United States
Grady Health System
RECRUITING

Atlanta, Georgia, 30303, United States
Groupe Hospitalier Diaconesses Croix Saint-Simon
RECRUITING

Paris, 75012, France
Huntington Memorial Hospital
RECRUITING

Pasadena, California, 91105, United States
Huntsman Cancer Institute University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States
Institut Gustave-Roussy
RECRUITING

Villejuif, FR, 94805, France
Institut Universitaire du Cancer de Toulouse - IUCT
RECRUITING

Toulouse, Occitanie, 31100, France
Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITING

Hamilton, Ontario, L8V 5C2, Canada
Lankenau Medical Center
RECRUITING

Wynnewood, Pennsylvania, 19096, United States
Leiden University Medical Center (LUMC)
RECRUITING

Leiden, 2333ZA, Netherlands
London Health Sciences Centre Research Inc.
RECRUITING

London, Ontario, N6A 5W9, Canada
M.D. Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
MC Haaglanden
RECRUITING

The Hague, South Holland, 432, Netherlands
Maastro clinic (Maastricht UMC)
RECRUITING

Maastricht, Limburg, 6229ET, Netherlands
Massachusetts General Hospital Cancer Center
RECRUITING

Boston, Massachusetts, 02114, United States
Mater Research Institute South Brisbane
RECRUITING

South Brisbane, Queensland, 4101, Australia
Medical College of Wisconsin
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Mercy Hospital
RECRUITING

Coon Rapids, Minnesota, 55433, United States
Monash Medical Centre
RECRUITING

Clayton, Victoria, 3168, Australia
Mount Sinai Chelsea
RECRUITING

New York, New York, 10011, United States
Mount Sinai Hospital
RECRUITING

New York, New York, 10029, United States
Nebraska Methodist Hospital
RECRUITING

Omaha, Nebraska, 68114, United States
Northwestern Medicine Cancer Center Warrenville
RECRUITING

Warrenville, Illinois, 60555, United States
Northwestern Medicine Orland Park
RECRUITING

Orland Park, Illinois, 60462, United States
Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States
Norton Hospital Pavilion and Medical Campus
RECRUITING

Louisville, Kentucky, 40202, United States
Norton Suburban Hospital and Medical Campus
RECRUITING

Louisville, Kentucky, 40207, United States
Odette Cancer Centre
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Ohio State University Comprehensive
RECRUITING

Columbus, Ohio, 43210, United States
Oslo University Hospital
RECRUITING

Oslo, Ullernchausseen 70, 0379, Norway
Paoli Memorial Hospital
RECRUITING

Paoli, Pennsylvania, 19301, United States
Penn State Milton S Hershey Medical Center
RECRUITING

Hershey, Pennsylvania, 17033, United States
Piedmont Hospital
RECRUITING

Atlanta, Georgia, 30309, United States
Policliico Careggi
RECRUITING

Florence, Florence, 50134, Italy
Policlinico Umberto I, Universita Sapienza
RECRUITING

Rome, 00161, Italy
Providence Portland Medical Centre
RECRUITING

Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
RECRUITING

Portland, Oregon, 97225, United States
Radiotherapiegroep
RECRUITING

Arnhem, Gelderland, 6815AD, Netherlands
Roswell Park Cancer Institute
RECRUITING

Buffalo, New York, 14263, United States
Royal Brisbane and Womens Hospital
RECRUITING

Herston, 4029, Australia
Royal North Shore Hospital
RECRUITING

St Leonards, New South Wales, 2065, Australia
Royal Victoria Regional Health Centre
RECRUITING

Barrie, Ontario, L4M 6M2, Canada
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING

Green Bay, Wisconsin, 54301, United States
Sarasota Memorial Health Care Centre
RECRUITING

Sarasota, Florida, 34243, United States
Sarasota Memorial Hospital
RECRUITING

Sarasota, Florida, 34239, United States
Sarasota Memorial Hospital - Venice
RECRUITING

N. Venice, Florida, 34275, United States
Sidney Kimmel Cancer Center Washington Township
RECRUITING

Sewell, New Jersey, 08080, United States
South Western Sydney Local Health District
RECRUITING

Liverpool, New South Wales, 2170, Australia
State University of New York
RECRUITING

Syracuse, New York, 13210, United States
Sutter Medical Center Sacramento
RECRUITING

Sacramento, California, 95816, United States
Swedish Medical Center First Hill
RECRUITING

Seattle, Washington, 98122, United States
The Jewish General Hospital
RECRUITING

Montreal, Quebec, H3T 1E2, Canada
The Royal Women's Hospital
RECRUITING

Parkville, Victoria, 3053, Australia
Thomas Jefferson University
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Trillium Health Partners - Credit Valley Hospital
RECRUITING

Mississauga, Ontario, L5M 2N1, Canada
UCHealth University of Colorado Hospital
RECRUITING

Aurora, Colorado, 80045, United States
UH Seidman Cancer Center
RECRUITING

Mentor, Ohio, 44060, United States
UH Seidman Cancer Center
RECRUITING

Westlake, Ohio, 44145, United States
UHHS-Chagrin Highlands Medical Center
RECRUITING

Beachwood, Ohio, 44122, United States
UM Sylvester Comprehensive Cancer Center
RECRUITING

Plantation, Florida, 33324, United States
UM Sylvester Comprehensive Cancer Center at
RECRUITING

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
RECRUITING

Doral, Florida, 33166, United States
UMass Memorial Medical Centre
RECRUITING

Worcester, Massachusetts, 01605, United States
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States
University Health Network
RECRUITING

Toronto, Ontario, M5G 2M9, Canada
University Hospitals Parma Medical Center
RECRUITING

Parma, Ohio, 44129, United States
University Medical Center New Orleans
RECRUITING

New Orleans, Louisiana, 70112, United States
University of Arizona Cancer Center
RECRUITING

Tucson, Arizona, 85719, United States
University of Florida
RECRUITING

Gainesville, Florida, 32610-0277, United States
University of Miami School of Medicine
RECRUITING

Miami, Florida, 33136, United States
University of Miami Sylvester
RECRUITING

North Miami, Florida, 33181, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Utah Sugarhouse Health Centre
RECRUITING

Salt Lake City, Utah, 84106, United States
University of Vermont Medical Center
RECRUITING

Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
RECRUITING

Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
RECRUITING

Charlottesville, Virginia, 22908, United States
Upstate Cancer Center Radiation Oncology at Oswego
RECRUITING

Oswego, New York, 13126, United States
Upstate Cancer Center at Hill Radiation Oncology
RECRUITING

Syracuse, New York, 13210, United States
Upstate Cancer Center at Verona
RECRUITING

Verona, New York, 13478, United States
Virginia Commonwealth University
RECRUITING

Richmond, Virginia, 23298, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
Westmead Hospital
RECRUITING

Westmead, New South Wales, 2145, Australia
Women and Infants Hospital
RECRUITING

Providence, Rhode Island, 02905, United States
Womens Cancer Center of Nevada
RECRUITING

Las Vegas, Nevada, 89106, United States

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