ClinicalTrials.gg
RecruitingNCT05640999Updated Nov 12, 2026

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

A Phase 2 interventional study of Vaginal brachytherapy and Adjuvant radiotherapy (EBRT +/- brachytherapy) in Endometrial Cancer, sponsored by Canadian Cancer Trials Group. Recruiting at 124 sites in 9 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Canadian Cancer Trials Group · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Updated Nov 12, 20264 sites added2 sites removedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
393
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 713 studies in Endometrial Neoplasms with a site in United States — 197 open to participants now, 286 under way, 22 of them phase 3. Endometrial Neoplasms · United States.

Planned enrollment
66th of 589
393 · median 60
Started
2022
with 33 others
Phase 2
178 of 713
35 open now
Primary completion
2028-12
later than 225 of 285 live
Registered
522nd of 713
by date

Among the 713 studies in Endometrial Neoplasms with a site in United States, this one is the 66th largest by planned enrollment of the 589 interventional ones that give a count, is one of 34 that started in 2022, is one of 178 in phase 2, reaches primary completion later than 225 of the 285 other live ones, and was the 522nd registered.

Endometrial Neoplasms

1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.

Browse Endometrial Neoplasms studies →

Open to participants now

197 of the 713 studies in Endometrial Neoplasms with a site in United States are open now. Recruiting first, the newest first:

192 more — sign in →

All 197 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 359 Endometrial Neoplasms studies recruiting now, 269 (75%) set no upper age limit and 54 (15%) stop at 75 or younger; 27 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 713 studies in Endometrial Neoplasms with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Endometrial Cancer
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
  • Patients' Eastern Cooperative Group () performance status must be 0, 1, or 2.
  • -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

Exclusion Criteria:

  • Prior chemotherapy for current endometrial cancer diagnosis.
  • Prior pelvic radiation.
  • Patients with a history of other , 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 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.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
393 participants (estimated)

Study arms

  • Experimental
    Sub-study A: RAINBO BLUE Cohort A1

    Observation

    Other: Observation

  • Experimental
    Sub-Study A: RAINBO BLUE Cohort A2

    Observation or Adjuvant Radiotherapy

    Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy) · Other: Observation

  • Experimental
    Sub-Study B: TAPER

    Observation or Vaginal Brachytherapy

    Radiation: Vaginal brachytherapy · Other: Observation

Interventions

  • RadiationVaginal brachytherapy

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

  • RadiationAdjuvant 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.

  • OtherObservation

    Observation

06

What researchers measure

Primary outcomes

  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

    Time frame: 3 years

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

  3. Estimate the rate of distant metastasis at 3 years

    Time frame: 3 years

  4. Estimate recurrence-free survival

    Time frame: 9 years

  5. Estimate endometrial cancer-specific survival

    Time frame: 9 years

  6. Estimate overall survival

    Time frame: 9 years

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

    Time frame: 9 years

07

Study locations

124 of 124 sites recruiting
  • Alaska Womens Cancer Care
    Anchorage, Alaska 99508, United States
    Recruiting
    • Melissa Hardesty · Contact907-212-6871
  • University of Arizona Cancer Center
    Tucson, Arizona 85719, United States
    Recruiting
    • Marina Miller · Contact
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
    • Emily Prendergast · Contact310-423-5246
  • Huntington Memorial Hospital
    Pasadena, California 91105, United States
    Recruiting
    • Emily Prendergast · Contact310-423-5246
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
    Recruiting
    • Anna Likhacheva · Contact
  • UCHealth University of Colorado Hospital
    Aurora, Colorado 80045, United States
    Recruiting
    • Bradley Corr · Contact
  • AdventHealth Porter
    Denver, Colorado 80210, United States
    Recruiting
    • Neil Phippen · Contact
  • UM Sylvester Comprehensive Cancer Center at
    Deerfield Beach, Florida 33442, United States
    Recruiting
    • Joseph Pearson · Contact
  • UM Sylvester Comprehensive Cancer Center at Doral
    Doral, Florida 33166, United States
    Recruiting
    • Joseph Pearson · Contact
  • University of Florida
    Gainesville, Florida 32610-0277, United States
    Recruiting
    • Danielle Cerbon · Contact352-265-0287
  • University of Miami School of Medicine
    Miami, Florida 33136, United States
    Recruiting
    • Joseph Pearson · Contact
  • Sarasota Memorial Hospital - Venice
    N. Venice, Florida 34275, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • University of Miami Sylvester
    North Miami, Florida 33181, United States
    Recruiting
    • Joseph Pearson · Contact
  • UM Sylvester Comprehensive Cancer Center
    Plantation, Florida 33324, United States
    Recruiting
    • Joseph Pearson · Contact
  • Florida Cancer Specialists - Sarasota Downtown
    Sarasota, Florida 34236, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • First Physicians Group-Sarasota
    Sarasota, Florida 34239, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • Sarasota Memorial Hospital
    Sarasota, Florida 34239, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • Sarasota Memorial Health Care Centre
    Sarasota, Florida 34243, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • Florida Cancer Specialists - Venice Pinebrook
    Venice, Florida 34275, United States
    Recruiting
    • Beverly Long · Contact941-917-2225
  • Grady Health System
    Atlanta, Georgia 30303, United States
    Recruiting
    • Jill Remick · Contact404-778-1900
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
    Recruiting
    • Jill Remick · Contact404-778-1900
  • Piedmont Hospital
    Atlanta, Georgia 30309, United States
    Recruiting
    • Leda Gattoc · Contact
  • Emory University Hospital Winship Cancer Institute
    Atlanta, Georgia 30322, United States
    Recruiting
    • Jill Remick · Contact404-778-1900
  • Emory Saint Josephs Hospital
    Atlanta, Georgia 30342, United States
    Recruiting
    • Jill Remick · Contact404-778-1900
  • Emory Decatur Hospital
    Decatur, Georgia 30033, United States
    Recruiting
    • Jill Remick · Contact404-778-1900
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
    • Dario Roque · Contact312-695-0990
  • Northwestern Medicine Orland Park
    Orland Park, Illinois 60462, United States
    Recruiting
    • Dario Roque · Contact312-695-0990
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois 60555, United States
    Recruiting
    • Dario Roque · Contact312-695-0990
  • Ascension Saint Vincent Indianapolis Hospital
    Indianapolis, Indiana 46260, United States
    Recruiting
    • Megan Buechel · Contact317-415-6740
  • Norton Hospital Pavilion and Medical Campus
    Louisville, Kentucky 40202, United States
    Recruiting
    • Monica Vetter · Contact502-899-3366
  • Norton Suburban Hospital and Medical Campus
    Louisville, Kentucky 40207, United States
    Recruiting
    • Monica Vetter · Contact502-899-3366
  • University Medical Center New Orleans
    New Orleans, Louisiana 70112, United States
    Recruiting
    • Tara Castellano · Contact504-210-3539
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
    Recruiting
    • Andrea Russo · Contact617-726-7941
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
    Recruiting
    • Tashanna Myers · Contact413-974-3565
  • UMass Memorial Medical Centre
    Worcester, Massachusetts 01605, United States
    Recruiting
    • Susan Zweizig · Contact508-856-6265
  • Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
    Recruiting
    • Annie Tan · Contact952-993-1517
  • Abbott-Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
    Recruiting
    • Alexandra Samborski · Contact952-993-1517
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
    Recruiting
    • Premal Thaker · Contact314-747-3604
  • Nebraska Methodist Hospital
    Omaha, Nebraska 68114, United States
    Recruiting
    • Brent Tierney · Contact402-354-5144
  • Womens Cancer Center of Nevada
    Las Vegas, Nevada 89106, United States
    Recruiting
    • Nicola Spirtos · Contact702-851-4672
  • Sidney Kimmel Cancer Center Washington Township
    Sewell, New Jersey 08080, United States
    Recruiting
    • Mitchell Edelson · Contact215-481-4000
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
    Recruiting
    • Emese Zsiros · Contact716-845-8337
  • Mount Sinai Chelsea
    New York, New York 10011, United States
    Recruiting
    • Caitlin Carr · Contact212-824-7309
  • Mount Sinai Hospital
    New York, New York 10029, United States
    Recruiting
    • Caitlin Carr · Contact212-824-7309
  • Upstate Cancer Center Radiation Oncology at Oswego
    Oswego, New York 13126, United States
    Recruiting
    • Mary Cunningham · Contact315-634-4112
  • State University of New York
    Syracuse, New York 13210, United States
    Recruiting
    • Mary Cunningham · Contact315-634-4112
  • Upstate Cancer Center at Hill Radiation Oncology
    Syracuse, New York 13210, United States
    Recruiting
    • Mary Cunningham · Contact315-634-4112
  • Upstate Cancer Center at Verona
    Verona, New York 13478, United States
    Recruiting
    • Mary Cunningham · Contact315-634-4112
  • UNC Lineberger Comprehensive Cancer Center
    Chapel Hill, North Carolina 27599, United States
    Recruiting
    • Olivia Lara · Contact877-668-0683
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
    • Angeles Secord · Contact
  • Duke Womens Cancer Care Raleigh
    Raleigh, North Carolina 27607, United States
    Recruiting
    • Angeles Secord · Contact
  • UHHS-Chagrin Highlands Medical Center
    Beachwood, Ohio 44122, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • Geauga Hospital
    Chardon, Ohio 44024, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • Ohio State University Comprehensive
    Columbus, Ohio 43210, United States
    Recruiting
    • Casey Cosgrove · Contact
  • UH Seidman Cancer Center
    Mentor, Ohio 44060, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • University Hospitals Parma Medical Center
    Parma, Ohio 44129, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • UH Seidman Cancer Center
    Westlake, Ohio 44145, United States
    Recruiting
    • Sarah Lynam · Contact216-844-3954
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
    Recruiting
    • Christina Washington · Contact405-271-8777
  • Providence Portland Medical Centre
    Portland, Oregon 97213, United States
    Recruiting
    • Alison Conlin · Contact503-215-6259
  • Providence Saint Vincent Medical Center
    Portland, Oregon 97225, United States
    Recruiting
    • Alison Conlin · Contact503-215-6259
  • Penn State Milton S Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
    Recruiting
    • Shaina Bruce · Contact717-531-3779
  • Paoli Memorial Hospital
    Paoli, Pennsylvania 19301, United States
    Recruiting
    • Paul Gilman · Contact484-476-2649
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
    Recruiting
    • Mitchell Edelson · Contact215-481-4000
  • Asplundh Cancer Pavilion
    Willow Grove, Pennsylvania 19090, United States
    Recruiting
    • Mitchell Edelson · Contact215-481-4000
  • Lankenau Medical Center
    Wynnewood, Pennsylvania 19096, United States
    Recruiting
    • Paul Gilman · Contact484-476-2649
  • Women and Infants Hospital
    Providence, Rhode Island 02905, United States
    Recruiting
    • Matthew Oliver · Contact401-274-1122
  • M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
    • Ann Klopp · Contact713-563-2444
  • Farmington Health Centre
    Farmington, Utah 84025, United States
    Recruiting
    • Cristina DeCesaris · Contact
  • University of Utah Sugarhouse Health Centre
    Salt Lake City, Utah 84106, United States
    Recruiting
    • Cristina DeCesaris · Contact
  • Huntsman Cancer Institute University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
    • Cristina DeCesaris · Contact
  • University of Vermont Medical Center
    Burlington, Vermont 05401, United States
    Recruiting
    • Puyao Li · Contact802-656-8990
  • University of Vermont and State Agricultural College
    Burlington, Vermont 05405, United States
    Recruiting
    • Puyao Li · Contact802-656-8990
  • University of Virginia Cancer Center
    Charlottesville, Virginia 22908, United States
    Recruiting
    • Kara Romano · Contact434-924-5191
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
    Recruiting
    • Emma Fields · Contact
  • Swedish Medical Center First Hill
    Seattle, Washington 98122, United States
    Recruiting
    • Charles Drescher · Contact206-991-2000
  • Saint Vincent Hospital Cancer Center Green Bay
    Green Bay, Wisconsin 54301, United States
    Recruiting
    • Matthew Ryan · Contact920-884-3135
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
    Recruiting
    • William Bradley · Contact414-805-6600
  • Canberra Hospital
    Garran, Australian Capital Territory 2605, Australia
    Recruiting
    • Andrew Douglas Lee · Contact
  • South Western Sydney Local Health District
    Liverpool, New South Wales 2170, Australia
    Recruiting
    • Viet Do · Contact
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
    Recruiting
    • Marita Morgia · Contact2 946-3130
  • Calvary Mater Newcastle Hospital
    Waratah, New South Wales 2298, Australia
    Recruiting
    • Geetha Govindarajulu · Contact
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
    Recruiting
    • Alison Brand · Contact
  • Royal Brisbane and Womens Hospital
    Herston, Queensland 4029, Australia
    Recruiting
    • Andrea Garrett · Contact73 646-8111
  • Mater Research Institute South Brisbane
    South Brisbane, Queensland 4101, Australia
    Recruiting
    • Nimithri Cabraal · Contact
  • Royal Darwin Hospital
    Darwin, Tiwi 0810, Australia
    Recruiting
    • Michelle Harris · Contact
  • Monash Medical Centre
    Clayton, Victoria 3168, Australia
    Recruiting
    • Shih-Ern Yao · Contact39 594-6666
  • Frankston Hospital
    Frankston, Victoria 3199, Australia
    Recruiting
    • Yoland Antill · Contact
  • The Royal Women's Hospital
    Parkville, Victoria 3053, Australia
    Recruiting
    • Orla McNally · Contact613 834-5356
  • Arthur J.E. Child Comprehensive Cancer Centre
    Calgary, Alberta T2N 5G2, Canada
    Recruiting
    • Ruth Fullerton · Contact403 521-3095
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
    Recruiting
    • Fleur Huang · Contact780 432-8516
  • BCCA - Kelowna
    Kelowna, British Columbia V1Y 5L3, Canada
    Recruiting
    • Hamid Raziee · Contact
  • BCCA - Prince George
    Prince George, British Columbia V2M 7E9, Canada
    Recruiting
    • Allison Ye · Contact250 645-7300
  • BCCA - Vancouver
    Vancouver, British Columbia V5Z 4E6, Canada
    Recruiting
    • Jessica McAlpine · Contact604 877-6000
  • BCCA - Victoria
    Victoria, British Columbia V8R 6V5, Canada
    Recruiting
    • Caroline Holloway · Contact250 519-5609
  • Royal Victoria Regional Health Centre
    Barrie, Ontario L4M 6M2, Canada
    Recruiting
    • Jessica Conway · Contact705 728-9090
  • Juravinski Cancer Centre at Hamilton Health Sciences
    Hamilton, Ontario L8V 5C2, Canada
    Recruiting
    • Clare Reade · Contact905 389-5688
  • London Health Sciences Centre Research Inc.
    London, Ontario N6A 5W9, Canada
    Recruiting
    • Lucas Mendez · Contact519 685-8600
  • Trillium Health Partners - Credit Valley Hospital
    Mississauga, Ontario L5M 2N1, Canada
    Recruiting
    • Katherine Pulman · Contact905 813-1100
  • Odette Cancer Centre
    Toronto, Ontario M4N 3M5, Canada
    Recruiting
    • Helen MacKay · Contact416 480-5145

Showing the first 100 of 124 sites across 9 countries. Choose a country and city above to see the rest.

08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Dec 2028, 72 months after the start.

Of 107 non-industry phase 2 interventional studies under Endometrial Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 115. This study's planned 72 months is above that.

Counting every sponsor, half of 139 studies reached it within 55 months; a quarter within 37 and three quarters within 115.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2022
First posted
Dec 7, 2022
StartActual
Dec 19, 2022
Primary completionEst.
Dec 31, 2028
CompletionEst.
Jun 30, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
4 sites added, 2 sites removed
Show 4 added (2 Australia, 1 France, 1 United States)
  • Centre Oscar Lambret · Lille, France
  • Abbott-Northwestern Hospital · Minneapolis, United States
  • Canberra Hospital · Garran, Australia
  • Royal Brisbane and Womens Hospital · Herston, Australia
Show 2 removed
  • Canberra Hospital · Garran, Australia
  • Royal Brisbane and Womens Hospital · Herston, Australia
across 2 updates, Oct 14, 2026 – Nov 12, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • University Health Network · Toronto, CanadaContact •••4501→•••4501
Nov 12, 2026
Show all 2 updates
  1. Nov 12, 2026
    3 sites added, 2 sites removed
    Show 3 added (2 Australia, 1 United States)
    • Abbott-Northwestern Hospital · Minneapolis, United States
    • Canberra Hospital · Garran, Australia
    • Royal Brisbane and Womens Hospital · Herston, Australia
    Show 2 removed
    • Canberra Hospital · Garran, Australia
    • Royal Brisbane and Womens Hospital · Herston, Australia
    Site contacts Changed at 1 site. See the sites
    Show the site
    • University Health Network · Toronto, CanadaContact •••4501→•••4501
  2. Oct 14, 2026
    1 site added
    Show site
    • Centre Oscar Lambret · Lille, France

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05640999
Lead sponsor
Canadian Cancer Trials Group
Collaborators
Canadian Cancer Clinical Trials Network, Australia New Zealand Gynaecological Oncology Group, Gustave Roussy, Cancer Campus, Grand Paris, Leiden University Medical Center, Mario Negri Gynecologic Oncology group (MaNGO), NRG Oncology, Philipps University Marburg, University College, London
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Dec 19, 2022
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Wendy Parulekar
Contact
wparulekar@ctg.queensu.ca
613-533-6430
Kathy Han
study chair · University Health Network, Princess Margaret Hospital, Toronto ON Canada
Jessica McAlpine
study chair · BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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