AzTrials
AzTrials

Endometrial CancerPhase 2NCT05640999

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

A Phase 2 study testing Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy) and Observation in people with Endometrial Cancer, run by Canadian Cancer Trials Group at 123 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy) and Observation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
393 participants
Where
123 sitesin 9 countries
Study dates
19 Dec 2022to 30 Jun 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

123 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Wendy Parulekar contact

613-533-6430

wparulekar@ctg.queensu.ca

123 sites in 9 countries

United States77 sites, 77 recruiting

  • Alaska Womens Cancer Care

    Anchorage, Alaska, 99508

    Melissa Hardesty, 907-212-6871

    Recruiting

  • Grady Health System

    Atlanta, Georgia, 30303

    Jill Remick, 404-778-1900

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Jill Remick, 404-778-1900

    Recruiting

  • Piedmont Hospital

    Atlanta, Georgia, 30309

    Leda Gattoc

    Recruiting

  • Emory University Hospital Winship Cancer Institute

    Atlanta, Georgia, 30322

    Jill Remick, 404-778-1900

    Recruiting

  • Emory Saint Josephs Hospital

    Atlanta, Georgia, 30342

    Jill Remick, 404-778-1900

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Bradley Corr

    Recruiting

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

    Sarah Lynam, 216-844-3954

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    Andrea Russo, 617-726-7941

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Emese Zsiros, 716-845-8337

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Puyao Li, 802-656-8990

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Puyao Li, 802-656-8990

    Recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

    Olivia Lara, 877-668-0683

    Recruiting

  • Geauga Hospital

    Chardon, Ohio, 44024

    Sarah Lynam, 216-844-3954

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Kara Romano, 434-924-5191

    Recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Dario Roque, 312-695-0990

    Recruiting

  • Case Western Reserve University

    Cleveland, Ohio, 44106

    Sarah Lynam, 216-844-3954

    Recruiting

  • Ohio State University Comprehensive

    Columbus, Ohio, 43210

    Casey Cosgrove

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Annie Tan, 952-993-1517

    Recruiting

  • Emory Decatur Hospital

    Decatur, Georgia, 30033

    Jill Remick, 404-778-1900

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at

    Deerfield Beach, Florida, 33442

    Joseph Pearson

    Recruiting

  • AdventHealth Porter

    Denver, Colorado, 80210

    Neil Phippen

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Joseph Pearson

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Angeles Secord

    Recruiting

  • Farmington Health Centre

    Farmington, Utah, 84025

    Cristina DeCesaris

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610-0277

    Danielle Cerbon, 352-265-0287

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Matthew Ryan, 920-884-3135

    Recruiting

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

    Shaina Bruce, 717-531-3779

    Recruiting

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

    Ann Klopp, 713-563-2444

    Recruiting

  • Ascension Saint Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

    Megan Buechel, 317-415-6740

    Recruiting

  • Womens Cancer Center of Nevada

    Las Vegas, Nevada, 89106

    Nicola Spirtos, 702-851-4672

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Emily Prendergast, 310-423-5246

    Recruiting

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

    Monica Vetter, 502-899-3366

    Recruiting

  • Norton Suburban Hospital and Medical Campus

    Louisville, Kentucky, 40207

    Monica Vetter, 502-899-3366

    Recruiting

  • UH Seidman Cancer Center

    Mentor, Ohio, 44060

    Sarah Lynam, 216-844-3954

    Recruiting

  • University of Miami School of Medicine

    Miami, Florida, 33136

    Joseph Pearson

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    William Bradley, 414-805-6600

    Recruiting

  • Sarasota Memorial Hospital - Venice

    N. Venice, Florida, 34275

    Beverly Long, 941-917-2225

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Tara Castellano, 504-210-3539

    Recruiting

  • Mount Sinai Chelsea

    New York, New York, 10011

    Caitlin Carr, 212-824-7309

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Caitlin Carr, 212-824-7309

    Recruiting

  • University of Miami Sylvester

    North Miami, Florida, 33181

    Joseph Pearson

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Christina Washington, 405-271-8777

    Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

    Brent Tierney, 402-354-5144

    Recruiting

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

    Dario Roque, 312-695-0990

    Recruiting

  • Upstate Cancer Center Radiation Oncology at Oswego

    Oswego, New York, 13126

    Mary Cunningham, 315-634-4112

    Recruiting

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

    Paul Gilman, 484-476-2649

    Recruiting

  • University Hospitals Parma Medical Center

    Parma, Ohio, 44129

    Sarah Lynam, 216-844-3954

    Recruiting

  • Huntington Memorial Hospital

    Pasadena, California, 91105

    Emily Prendergast, 310-423-5246

    Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

    Mitchell Edelson, 215-481-4000

    Recruiting

  • UM Sylvester Comprehensive Cancer Center

    Plantation, Florida, 33324

    Joseph Pearson

    Recruiting

  • Providence Portland Medical Centre

    Portland, Oregon, 97213

    Alison Conlin, 503-215-6259

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Alison Conlin, 503-215-6259

    Recruiting

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

    Matthew Oliver, 401-274-1122 ext. 48181

    Recruiting

  • Duke Womens Cancer Care Raleigh

    Raleigh, North Carolina, 27607

    Angeles Secord

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Emma Fields

    Recruiting

  • Sutter Medical Center Sacramento

    Sacramento, California, 95816

    Anna Likhacheva

    Recruiting

  • University of Utah Sugarhouse Health Centre

    Salt Lake City, Utah, 84106

    Cristina DeCesaris

    Recruiting

  • Huntsman Cancer Institute University of Utah

    Salt Lake City, Utah, 84112

    Cristina DeCesaris

    Recruiting

  • Florida Cancer Specialists - Sarasota Downtown

    Sarasota, Florida, 34236

    Beverly Long, 941-917-2225

    Recruiting

  • First Physicians Group-Sarasota

    Sarasota, Florida, 34239

    Beverly Long, 941-917-2225

    Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

    Beverly Long, 941-917-2225

    Recruiting

  • Sarasota Memorial Health Care Centre

    Sarasota, Florida, 34243

    Beverly Long, 941-917-2225

    Recruiting

  • Swedish Medical Center First Hill

    Seattle, Washington, 98122

    Charles Drescher, 206-991-2000

    Recruiting

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

    Mitchell Edelson, 215-481-4000

    Recruiting

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

    Tashanna Myers, 413-974-3565

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Premal Thaker, 314-747-3604

    Recruiting

  • State University of New York

    Syracuse, New York, 13210

    Mary Cunningham, 315-634-4112

    Recruiting

  • Upstate Cancer Center at Hill Radiation Oncology

    Syracuse, New York, 13210

    Mary Cunningham, 315-634-4112

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Marina Miller

    Recruiting

  • Florida Cancer Specialists - Venice Pinebrook

    Venice, Florida, 34275

    Beverly Long, 941-917-2225

    Recruiting

  • Upstate Cancer Center at Verona

    Verona, New York, 13478

    Mary Cunningham, 315-634-4112

    Recruiting

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Dario Roque, 312-695-0990

    Recruiting

  • UH Seidman Cancer Center

    Westlake, Ohio, 44145

    Sarah Lynam, 216-844-3954

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

    Mitchell Edelson, 215-481-4000

    Recruiting

  • UMass Memorial Medical Centre

    Worcester, Massachusetts, 01605

    Susan Zweizig, 508-856-6265

    Recruiting

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

    Paul Gilman, 484-476-2649

    Recruiting

Other trials in United States

Canada15 sites, 15 recruiting

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

    Jessica Conway, 705 728-9090

    Recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Ruth Fullerton, 403 521-3095

    Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Fleur Huang, 780 432-8516

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Clare Reade, 905 389-5688

    Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

    Hamid Raziee

    Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

    Lucas Mendez, 519 685-8600 ext. 53169

    Recruiting

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

    Katherine Pulman, 905 813-1100 ext. 1841

    Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Maroie Barkati, 514 890-8254

    Recruiting

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Susie K.S. Lau, 514 340-8222 ext. 3114

    Recruiting

  • BCCA - Prince George

    Prince George, British Columbia, V2M 7E9

    Allison Ye, 250 645-7300

    Recruiting

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

    Mathieu Viau

    Recruiting

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

    Helen MacKay, 416 480-5145

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Kathy Han, 416 946-4501 ext. 2919

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Jessica McAlpine, 604 877-6000 ext. 2395

    Recruiting

  • BCCA - Victoria

    Victoria, British Columbia, V8R 6V5

    Caroline Holloway, 250 519-5609

    Recruiting

Other trials in Canada

Australia11 sites, 11 recruiting

  • Monash Medical Centre

    Clayton, Victoria, 3168

    Shih-Ern Yao, 39 594-6666

    Recruiting

  • Royal Darwin Hospital

    Darwin, Tiwi, 0810

    Michelle Harris

    Recruiting

  • Frankston Hospital

    Frankston, Victoria, 3199

    Yoland Antill

    Recruiting

  • Canberra Hospital

    Garran, ACT 2605

    Andrew Douglas Lee

    Recruiting

  • Royal Brisbane and Womens Hospital

    Herston, 4029

    Andrea Garrett, 73 646-8111

    Recruiting

  • South Western Sydney Local Health District

    Liverpool, New South Wales, 2170

    Viet Do

    Recruiting

  • The Royal Women's Hospital

    Parkville, Victoria, 3053

    Orla McNally, 613 834-5356 ext. 2

    Recruiting

  • Mater Research Institute South Brisbane

    South Brisbane, Queensland, 4101

    Nimithri Cabraal

    Recruiting

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

    Marita Morgia, 2 946-3130

    Recruiting

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, 2298

    Geetha Govindarajulu

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Alison Brand

    Recruiting

Other trials in Australia

Netherlands6 sites, 6 recruiting

  • Radiotherapiegroep

    Arnhem, Gelderland, 6815AD

    Dorien Haverkort, 318 877-9000

    Recruiting

  • Catharina ziekenhuis

    Eindhoven, North Brabant, 5623 EJ

    Bastiaan Wortman, 40 239-9111

    Recruiting

  • Leiden University Medical Center (LUMC)

    Leiden, 2333ZA

    Stephanie De Boer

    Recruiting

  • Maastro clinic (Maastricht UMC)

    Maastricht, Limburg, 6229ET

    Nienke Kuijsters, 31 088-4456 ext. 0

    Recruiting

  • Erasmus Medical Center (EMC)

    Rotterdam

    Henrieke Westerveld

    Recruiting

  • MC Haaglanden

    The Hague, South Holland, 432

    Mandy Kiderlen, 3 889-7979

    Recruiting

Other trials in Netherlands

France5 sites, 5 recruiting

  • Centre Oscar Lambret

    Lille, Nord, 59000

    Abel Cardoba Largo

    Recruiting

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

    Olivia Le Saux, 47 878-2828

    Recruiting

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris, 75012

    Frederic Selle, 33 144-6437

    Recruiting

  • Institut Universitaire du Cancer de Toulouse - IUCT

    Toulouse, Occitanie, 31100

    Laurence Gladieff

    Recruiting

  • Institut Gustave-Roussy

    Villejuif, FR, 94805

    Alexandra Leary, 33 142-1142 ext. 11

    Recruiting

Other trials in France

Italy5 sites, 5 recruiting

  • ASST Spedali Civili Brescia

    Brescia, 25123

    Germana Tognon

    Recruiting

  • Policliico Careggi

    Florence, Florence, 50134

    Maria Cristina Petrella

    Recruiting

  • ASST Lecco

    Lecco, 23900

    Romerai D'Amico

    Recruiting

  • European Institute of Oncology

    Milan, 20141

    Ilaria Betella, 39 025-7489

    Recruiting

  • Policlinico Umberto I, Universita Sapienza

    Rome, 00161

    Federica Tomao

    Recruiting

Other trials in Italy

New Zealand2 sites, 2 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Ruth Angell

    Recruiting

  • Christchurch Hospital

    Christchurch, 8140

    Bryony Simcock

    Recruiting

Other trials in New Zealand

Germany1 site, 1 recruiting

  • Diak Klinikum Landkreis Schwaebisch Hall

    Schwäbisch Hall, Baden-Wurttemberg, 74523

    Stefan Kommoss

    Recruiting

Other trials in Germany

Norway1 site, 1 recruiting

  • Oslo University Hospital

    Oslo, Ullernchausseen 70, 0379

    Kristina Lindemann, 2 293-4983

    Recruiting

Other trials in Norway

About this study

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

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
Read the 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.

Being tested
Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy), Observation
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaginal brachytherapyRadiation

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

  • Adjuvant radiotherapy (EBRT +/- brachytherapy)Radiation

    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.

  • ObservationOther

    Observation

Study groups in NCT05640999
Study groupRoleWhat they receive
Sub-study A: RAINBO BLUE Cohort A1ExperimentalObservation
Receives: Other: Observation
Sub-Study A: RAINBO BLUE Cohort A2ExperimentalObservation or Adjuvant Radiotherapy
Receives: Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy); Other: Observation
Sub-Study B: TAPERExperimentalObservation or Vaginal Brachytherapy
Receives: Radiation: Vaginal brachytherapy; Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status

    Measured: 3 years

Secondary outcomes (7)

  1. Estimate the rate of isolated vaginal recurrence at 3 years

    Measured: 3 years

  2. Estimate the rate of para-aortic recurrence at 3 years

    Measured: 3 years

  3. Estimate the rate of distant metastasis at 3 years

    Measured: 3 years

  4. Estimate recurrence-free survival

    Measured: 9 years

  5. Estimate endometrial cancer-specific survival

    Measured: 9 years

  6. Estimate overall survival

    Measured: 9 years

  7. Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory

    Measured: 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2022
  2. Study start19 Dec 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
393 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05640999
Sponsor's protocol ID
EN10
Other IDs
NRG-GY032
Status last verified
Aug 2026
First submitted
29 Nov 2022
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vaginal brachytherapy, Adjuvant radiotherapy (EBRT +/- brachytherapy) and Observation in people with Endometrial Cancer, run by Canadian Cancer Trials Group at 123 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Canada, Australia, Netherlands, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wendy Parulekar (613-533-6430, wparulekar@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05640999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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Clinical Trial NCT05640999 | AzTrials