Recruiting
Phase 2

RAINBO BLUE & TAPER

Sponsor:

Canadian Cancer Trials Group

Code:

NCT05640999

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vaginal brachytherapy

Adjuvant radiotherapy (EBRT +/- brachytherapy)

Observation

Study Details

Brief 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

Conditions

Endometrial Cancer

Study ID

NCT05640999

Start date

Dec 19, 2022

Status verified date

Aug, 2026

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

393 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Vaginal brachytherapy

Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

Adjuvant radiotherapy (EBRT +/- brachytherapy)

Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.

Observation

Observation

Primary outcome measure

  • Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Wendy Parulekar

613-533-6430wparulekar@ctg.queensu.ca

Locations

Alaska Womens Cancer Care

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Melissa Hardesty

907-212-6871

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Emily Prendergast

310-423-5246

Huntington Memorial Hospital

Recruiting

Pasadena, California, United States, 91105

Contacts

Emily Prendergast

310-423-5246

Sutter Medical Center Sacramento

Recruiting

Sacramento, California, United States, 95816

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

AdventHealth Porter

Recruiting

Denver, Colorado, United States, 80210

UM Sylvester Comprehensive Cancer Center at Doral

Recruiting

Doral, Florida, United States, 33166

University of Florida

Recruiting

Gainesville, Florida, United States, 32610-0277

Contacts

Danielle Cerbon

352-265-0287

University of Miami School of Medicine

Recruiting

Miami, Florida, United States, 33136

Sarasota Memorial Hospital - Venice

Recruiting

N. Venice, Florida, United States, 34275

Contacts

Beverly Long

941-917-2225

University of Miami Sylvester

Recruiting

North Miami, Florida, United States, 33181

UM Sylvester Comprehensive Cancer Center

Recruiting

Plantation, Florida, United States, 33324

Florida Cancer Specialists - Sarasota Downtown

Recruiting

Sarasota, Florida, United States, 34236

Contacts

Beverly Long

941-917-2225

First Physicians Group-Sarasota

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Beverly Long

941-917-2225

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Beverly Long

941-917-2225

Sarasota Memorial Health Care Centre

Recruiting

Sarasota, Florida, United States, 34243

Contacts

Beverly Long

941-917-2225

Florida Cancer Specialists - Venice Pinebrook

Recruiting

Venice, Florida, United States, 34275

Contacts

Beverly Long

941-917-2225

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Jill Remick

404-778-1900

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Jill Remick

404-778-1900

Piedmont Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Emory University Hospital Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jill Remick

404-778-1900

Emory Saint Josephs Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Jill Remick

404-778-1900

Emory Decatur Hospital

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Jill Remick

404-778-1900

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Dario Roque

312-695-0990

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Dario Roque

312-695-0990

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Dario Roque

312-695-0990

Ascension Saint Vincent Indianapolis Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Megan Buechel

317-415-6740

Norton Hospital Pavilion and Medical Campus

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Monica Vetter

502-899-3366

Norton Suburban Hospital and Medical Campus

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Monica Vetter

502-899-3366

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Tara Castellano

504-210-3539

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Andrea Russo

617-726-7941

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Tashanna Myers

413-974-3565

UMass Memorial Medical Centre

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Susan Zweizig

508-856-6265

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Premal Thaker

314-747-3604

Nebraska Methodist Hospital

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Brent Tierney

402-354-5144

Womens Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Nicola Spirtos

702-851-4672

Sidney Kimmel Cancer Center Washington Township

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Mitchell Edelson

215-481-4000

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Emese Zsiros

716-845-8337

Mount Sinai Chelsea

Recruiting

New York, New York, United States, 10011

Contacts

Caitlin Carr

212-824-7309

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Caitlin Carr

212-824-7309

Upstate Cancer Center Radiation Oncology at Oswego

Recruiting

Oswego, New York, United States, 13126

Contacts

Mary Cunningham

315-634-4112

State University of New York

Recruiting

Syracuse, New York, United States, 13210

Contacts

Mary Cunningham

315-634-4112

Upstate Cancer Center at Hill Radiation Oncology

Recruiting

Syracuse, New York, United States, 13210

Contacts

Mary Cunningham

315-634-4112

Upstate Cancer Center at Verona

Recruiting

Verona, New York, United States, 13478

Contacts

Mary Cunningham

315-634-4112

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Olivia Lara

877-668-0683

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Duke Womens Cancer Care Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

UHHS-Chagrin Highlands Medical Center

Recruiting

Beachwood, Ohio, United States, 44122

Contacts

Sarah Lynam

216-844-3954

Geauga Hospital

Recruiting

Chardon, Ohio, United States, 44024

Contacts

Sarah Lynam

216-844-3954

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Sarah Lynam

216-844-3954

Ohio State University Comprehensive

Recruiting

Columbus, Ohio, United States, 43210

UH Seidman Cancer Center

Recruiting

Mentor, Ohio, United States, 44060

Contacts

Sarah Lynam

216-844-3954

University Hospitals Parma Medical Center

Recruiting

Parma, Ohio, United States, 44129

Contacts

Sarah Lynam

216-844-3954

UH Seidman Cancer Center

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Sarah Lynam

216-844-3954

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Christina Washington

405-271-8777

Providence Portland Medical Centre

Recruiting

Portland, Oregon, United States, 97213

Contacts

Alison Conlin

503-215-6259

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Alison Conlin

503-215-6259

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Shaina Bruce

717-531-3779

Paoli Memorial Hospital

Recruiting

Paoli, Pennsylvania, United States, 19301

Contacts

Paul Gilman

484-476-2649

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Mitchell Edelson

215-481-4000

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Mitchell Edelson

215-481-4000

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Paul Gilman

484-476-2649

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Matthew Oliver

401-274-1122

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Ann Klopp

713-563-2444

Farmington Health Centre

Recruiting

Farmington, Utah, United States, 84025

University of Utah Sugarhouse Health Centre

Recruiting

Salt Lake City, Utah, United States, 84106

Huntsman Cancer Institute University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Puyao Li

802-656-8990

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Puyao Li

802-656-8990

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Kara Romano

434-924-5191

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Swedish Medical Center First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Charles Drescher

206-991-2000

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Matthew Ryan

920-884-3135

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

William Bradley

414-805-6600

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Ruth Fullerton

403 521-3095

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Contacts

Fleur Huang

780 432-8516

BCCA - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

BCCA - Prince George

Recruiting

Prince George, British Columbia, Canada, V2M 7E9

Contacts

Allison Ye

250 645-7300

BCCA - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Jessica McAlpine

604 877-6000

BCCA - Victoria

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Contacts

Caroline Holloway

250 519-5609

Royal Victoria Regional Health Centre

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Jessica Conway

705 728-9090

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Contacts

Clare Reade

905 389-5688

London Health Sciences Centre Research Inc.

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Lucas Mendez

519 685-8600

Trillium Health Partners - Credit Valley Hospital

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Katherine Pulman

905 813-1100

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Helen MacKay

416 480-5145

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Kathy Han

416 946-4501

CHUM-Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Maroie Barkati

514 890-8254

The Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Susie K.S. Lau

514 340-8222

CIUSSS de l'Estrie - Centre hospitalier

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-08-27.