Comparing 3 approaches for endometrial cancer
Official title: Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
- Phase 2
- 3 groups
- Sites in Calgary, Edmonton and 11 more cities
- Recruiting
Interventions
- Radiation therapy
Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
- Radiation therapy
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.
- Other intervention
Observation
Observation
Canadian Sites (15)
15 of 15 recruiting
- Recruiting
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
- Recruiting
BCCA - Kelowna
Kelowna, British Columbia
- Recruiting
BCCA - Prince George
Prince George, British Columbia
- Recruiting
BCCA - Vancouver
Vancouver, British Columbia
- Recruiting
BCCA - Victoria
Victoria, British Columbia
- Recruiting
Royal Victoria Regional Health Centre
Barrie, Ontario
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
London Health Sciences Centre Research Inc.
London, Ontario
- Recruiting
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario
- Recruiting
Odette Cancer Centre
Toronto, Ontario
- Recruiting
University Health Network
Toronto, Ontario
- Recruiting
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec
- Recruiting
The Jewish General Hospital
Montreal, Quebec
- Recruiting
CIUSSS de l'Estrie - Centre hospitalier
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
- +HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- +Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
- +Patients' age must be ≥ 18 years.
- +Patient consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Patients enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → on this trial must be treated and followed at the participating centre
- +ProtocolProtocolThe detailed plan a study must follow.Read more → treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
- +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.
Exclusion
- −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.
- −Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- −Prior pelvic radiation.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 3 groups in this study.
Group A receives Observation.
Registry label: A: Sub-study A: RAINBO BLUE Cohort A1
Group B receives one or more of: Adjuvant radiotherapy (EBRT +/- brachytherapy) and Observation.
Registry label: B: Sub-Study A: RAINBO BLUE Cohort A2
Group C receives one or more of: Vaginal brachytherapy and Observation.
Registry label: C: Sub-Study B: TAPER
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Groups are assigned by the study team using set rules, rather than by chance.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 393 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
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 over 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05640999 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Vaginal brachytherapyRadiation
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About 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.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About ObservationOther
Observation
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Groups are assigned by the study team using set rules, rather than by chance.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 years.
The study as a whole is currently expected to finish around 2029-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 393 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 19 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Prince George, British Columbia, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada, and 13 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Other Sites (8)
Roswell Park Cancer Institute
Buffalo, New York, United States
Mount Sinai Chelsea
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Upstate Cancer Center Radiation Oncology at Oswego
Oswego, New York, United States
State University of New York
Syracuse, New York, United States
Upstate Cancer Center at Hill Radiation Oncology
Syracuse, New York, United States
Upstate Cancer Center at Verona
Verona, New York, United States
Swedish Medical Center First Hill
Seattle, Washington, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.