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

Status: Recruiting
Location: See all (85) locations...
Intervention Type: Radiation, Other
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Womens Cancer Care
RECRUITING
Anchorage
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Huntington Memorial Hospital
RECRUITING
Pasadena
Sutter Medical Center Sacramento
RECRUITING
Sacramento
Colorado
UCHealth University of Colorado Hospital
RECRUITING
Aurora
Florida
Sarasota Memorial Hospital - Venice
RECRUITING
N. Venice
First Physicians Group-Sarasota
RECRUITING
Sarasota
Florida Cancer Specialists - Sarasota Downtown
RECRUITING
Sarasota
Sarasota Memorial Health Care Centre
RECRUITING
Sarasota
Sarasota Memorial Hospital
RECRUITING
Sarasota
Florida Cancer Specialists - Venice Pinebrook
RECRUITING
Venice
Georgia
Emory Saint Josephs Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Emory University Hospital Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Piedmont Hospital
RECRUITING
Atlanta
Emory Decatur Hospital
RECRUITING
Decatur
Illinois
Northwestern University
RECRUITING
Chicago
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Indiana
Ascension Saint Vincent Indianapolis Hospital
RECRUITING
Indianapolis
Louisiana
University Medical Center New Orleans
RECRUITING
New Orleans
Massachusetts
UMass Memorial Medical Centre
RECRUITING
Worcester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Duke University Medical Center
RECRUITING
Durham
Duke Womens Cancer Care Raleigh
RECRUITING
Raleigh
New Jersey
Sidney Kimmel Cancer Center Washington Township
RECRUITING
Sewell
Nevada
Womens Cancer Center of Nevada
RECRUITING
Las Vegas
New York
Mount Sinai Chelsea
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
Upstate Cancer Center Radiation Oncology at Oswego
RECRUITING
Oswego
State University of New York
RECRUITING
Syracuse
Upstate Cancer Center at Hill Radiation Oncology
RECRUITING
Syracuse
Upstate Cancer Center at Verona
RECRUITING
Verona
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Ohio State University Comprehensive
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Portland Medical Centre
RECRUITING
Portland
Pennsylvania
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
Thomas Jefferson University
RECRUITING
Philadelphia
Asplundh Cancer Pavilion
RECRUITING
Willow Grove
Rhode Island
Women and Infants Hospital
RECRUITING
Providence
Texas
M.D. Anderson Cancer Center
RECRUITING
Houston
Utah
Farmington Health Centre
RECRUITING
Farmington
Huntsman Cancer Institute University of Utah
RECRUITING
Salt Lake City
University of Utah Sugarhouse Health Centre
RECRUITING
Salt Lake City
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
Virginia Commonwealth University
RECRUITING
Richmond
Washington
Swedish Medical Center First Hill
RECRUITING
Seattle
Wisconsin
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Monash Medical Centre
RECRUITING
Clayton
Frankston Hospital
RECRUITING
Frankston
Canberra Hospital
RECRUITING
Garran
Royal Brisbane and Womens Hospital
RECRUITING
Herston
South Western Sydney Local Health District
RECRUITING
Liverpool
The Royal Women's Hospital
RECRUITING
Parkville
Mater Research Institute South Brisbane
RECRUITING
South Brisbane
Calvary Mater Newcastle Hospital
RECRUITING
Waratah
Westmead Hospital
RECRUITING
Westmead
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
Cross Cancer Institute
RECRUITING
Edmonton
BCCA - Kelowna
RECRUITING
Kelowna
London Health Sciences Centre Research Inc.
RECRUITING
London
Trillium Health Partners - Credit Valley Hospital
RECRUITING
Mississauga
CHUM-Centre Hospitalier de l'Universite de Montreal
RECRUITING
Montreal
The Jewish General Hospital
RECRUITING
Montreal
BCCA - Prince George
RECRUITING
Prince George
CIUSSS de l'Estrie - Centre hospitalier
RECRUITING
Sherbrooke
Odette Cancer Centre
RECRUITING
Toronto
University Health Network
RECRUITING
Toronto
BCCA - Vancouver
RECRUITING
Vancouver
BCCA - Victoria
RECRUITING
Victoria
France
Institut Universitaire du Cancer de Toulouse - IUCT
NOT_YET_RECRUITING
Toulouse
Institut Gustave-Roussy
RECRUITING
Villejuif
Italy
European Institute of Oncology
RECRUITING
Milan
Netherlands
Radiotherapiegroep
RECRUITING
Arnhem
Catharina ziekenhuis
RECRUITING
Eindhoven
Leiden University Medical Center (LUMC)
RECRUITING
Leiden
Maastro clinic (Maastricht UMC)
RECRUITING
Maastricht
Erasmus Medical Center (EMC)
RECRUITING
Rotterdam
MC Haaglanden
RECRUITING
The Hague
New Zealand
Auckland City Hospital
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Contact Information
Primary
Wendy Parulekar
wparulekar@ctg.queensu.ca
613-533-6430
Time Frame
Start Date: 2022-12-19
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 393
Treatments
Experimental: Sub-study A: RAINBO BLUE Cohort A1
Observation
Experimental: Sub-Study A: RAINBO BLUE Cohort A2
Observation or Adjuvant Radiotherapy
Experimental: Sub-Study B: TAPER
Observation or Vaginal Brachytherapy
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Cancer Clinical Trials Network
Leads: Canadian Cancer Trials Group

This content was sourced from clinicaltrials.gov