Back to Trials
NCT05640999PHASE2Recruiting

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

Canadian Cancer Trials Group

Start Date

12/19/2022

Completion Date

6/30/2029

Summary

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

Detailed Description

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer. The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

RADIATION

Vaginal brachytherapy

RADIATION

Adjuvant radiotherapy (EBRT +/- brachytherapy)

OTHER

Observation

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Endometrial Cancer

Locations

Alaska Womens Cancer Care

Anchorage, Alaska 99508

United States

University of Arizona Cancer Center

Tucson, Arizona 85719

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Huntington Memorial Hospital

Pasadena, California 91105

United States

Sutter Medical Center Sacramento

Sacramento, California 95816

United States

UCHealth University of Colorado Hospital

Aurora, Colorado 80045

United States

AdventHealth Porter

Denver, Colorado 80210

United States

University of Florida

Gainesville, Florida 32610-0277

United States

University of Miami School of Medicine

Miami, Florida 33136

United States

Sarasota Memorial Hospital - Venice

N. Venice, Florida 34275

United States

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida 34236

United States

First Physicians Group-Sarasota

Sarasota, Florida 34239

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

Sarasota Memorial Health Care Centre

Sarasota, Florida 34243

United States

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida 34275

United States

Grady Health System

Atlanta, Georgia 30303

United States

Emory University Hospital Midtown

Atlanta, Georgia 30308

United States

Piedmont Hospital

Atlanta, Georgia 30309

United States

Emory University Hospital Winship Cancer Institute

Atlanta, Georgia 30322

United States

Emory Saint Josephs Hospital

Atlanta, Georgia 30342

United States

Emory Decatur Hospital

Decatur, Georgia 30033

United States

Northwestern University

Chicago, Illinois 60611

United States

Northwestern Medicine Orland Park

Orland Park, Illinois 60462

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois 60555

United States

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana 46260

United States

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky 40202

United States

Norton Suburban Hospital and Medical Campus

Louisville, Kentucky 40207

United States

University Medical Center New Orleans

New Orleans, Louisiana 70112

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts 02114

United States

Baystate Medical Center

Springfield, Massachusetts 01199

United States

UMass Memorial Medical Centre

Worcester, Massachusetts 01605

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Nebraska Methodist Hospital

Omaha, Nebraska 68114

United States

Womens Cancer Center of Nevada

Las Vegas, Nevada 89106

United States

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey 08080

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

Mount Sinai Chelsea

New York, New York 10011

United States

Mount Sinai Hospital

New York, New York 10029

United States

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York 13126

United States

State University of New York

Syracuse, New York 13210

United States

Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York 13210

United States

Upstate Cancer Center at Verona

Verona, New York 13478

United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina 27599

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Duke Womens Cancer Care Raleigh

Raleigh, North Carolina 27607

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio 44122

United States

Geauga Hospital

Chardon, Ohio 44024

United States

Case Western Reserve University

Cleveland, Ohio 44106

United States

Ohio State University Comprehensive

Columbus, Ohio 43210

United States

UH Seidman Cancer Center

Mentor, Ohio 44060

United States

University Hospitals Parma Medical Center

Parma, Ohio 44129

United States

UH Seidman Cancer Center

Westlake, Ohio 44145

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Providence Portland Medical Centre

Portland, Oregon 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon 97225

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Paoli Memorial Hospital

Paoli, Pennsylvania 19301

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania 19090

United States

Lankenau Medical Center

Wynnewood, Pennsylvania 19096

United States

Women and Infants Hospital

Providence, Rhode Island 02905

United States

M.D. Anderson Cancer Center

Houston, Texas 77030

United States

Farmington Health Centre

Farmington, Utah 84025

United States

University of Utah Sugarhouse Health Centre

Salt Lake City, Utah 84106

United States

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah 84112

United States

University of Vermont Medical Center

Burlington, Vermont 05401

United States

University of Vermont and State Agricultural College

Burlington, Vermont 05405

United States

University of Virginia Cancer Center

Charlottesville, Virginia 22908

United States

Virginia Commonwealth University

Richmond, Virginia 23298

United States

Swedish Medical Center First Hill

Seattle, Washington 98122

United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin 54301

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

South Western Sydney Local Health District

Liverpool, New South Wales 2170

Australia

Royal North Shore Hospital

St Leonards, New South Wales 2065

Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales 2298

Australia

Westmead Hospital

Westmead, New South Wales 2145

Australia

Mater Research Institute South Brisbane

South Brisbane, Queensland 4101

Australia

Monash Medical Centre

Clayton, Victoria 3168

Australia

Frankston Hospital

Frankston, Victoria 3199

Australia

The Royal Women's Hospital

Parkville, Victoria 3053

Australia

Canberra Hospital

Garran, ACT 2605

Australia

Royal Brisbane and Womens Hospital

Herston, 4029

Australia

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2

Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

BCCA - Kelowna

Kelowna, British Columbia V1Y 5L3

Canada

BCCA - Prince George

Prince George, British Columbia V2M 7E9

Canada

BCCA - Vancouver

Vancouver, British Columbia V5Z 4E6

Canada

BCCA - Victoria

Victoria, British Columbia V8R 6V5

Canada

Royal Victoria Regional Health Centre

Barrie, Ontario L4M 6M2

Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario L8V 5C2

Canada

London Health Sciences Centre Research Inc.

London, Ontario N6A 5W9

Canada

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario L5M 2N1

Canada

Odette Cancer Centre

Toronto, Ontario M4N 3M5

Canada

University Health Network

Toronto, Ontario M5G 2M9

Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec H2X 3E4

Canada

The Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec J1H 5N4

Canada

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes 69008

France

Institut Gustave-Roussy

Villejuif, FR 94805

France

Institut Universitaire du Cancer de Toulouse - IUCT

Toulouse, Occitanie 31100

France

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, 75012

France

ASST Spedali Civili Brescia

Brescia, 25123

Italy

ASST Lecco

Lecco, 23900

Italy

European Institute of Oncology

Milan, 20141

Italy

Policlinico Umberto I, Universita Sapienza

Rome, 00161

Italy

Radiotherapiegroep

Arnhem, Gelderland 6815AD

Netherlands

Maastro clinic (Maastricht UMC)

Maastricht, Limburg 6229ET

Netherlands

Catharina ziekenhuis

Eindhoven, North Brabant 5623 EJ

Netherlands

MC Haaglanden

The Hague, South Holland 432

Netherlands

Leiden University Medical Center (LUMC)

Leiden, 2333ZA

Netherlands

Erasmus Medical Center (EMC)

Rotterdam,

Netherlands

Auckland City Hospital

Auckland, 1023

New Zealand

Christchurch Hospital

Christchurch, 8140

New Zealand

Oslo University Hospital

Oslo, Ullernchausseen 70 0379

Norway