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Adjuvant Therapy for Early-Stage Endometrial Cancer

This study is for women with early-stage endometrial cancer (cancer of the uterus lining) that has specific genetic features (POLE-mutated or p53 wildtype/no specific molecular profile). You must have already had surgery to remove your uterus and ovaries. Researchers want to see if a less intensive treatment after surgery, like vaginal brachytherapy (a type of radiation therapy delivered inside the vagina) or other adjuvant radiotherapy (radiation therapy given after surgery), is as effective as the usual approach. The main goal is to measure how many patients have their cancer return in the pelvis after three years with this de-escalated treatment. The study is currently recruiting about 393 participants.

Study design
This interventional study aims to enroll 393 participants into two sub-studies based on their tumor's molecular status. It compares different radiation therapies or observation to the usual care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will estimate the rate of pelvic recurrence at 3 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05640999

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Canadian Cancer Trials Group
~393 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Vaginal brachytherapyAdjuvant radiotherapy (EBRT +/- brachytherapy)Observation

At a glance

Recruiting sites
118 of 118 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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

Conditions

Endometrial Cancer

Explore related trials

Endometrial CarcinomaCellular Tumor Antigen p53POLE GeneReticulon-1

Where it's being run

118 sites across 50 states
Florida11
New York7
Ohio7
Georgia6
Ontario6
Pennsylvania5
New South Wales4
British Columbia4

Study leadership

  • Kathy Han · STUDY_CHAIR · University Health Network, Princess Margaret Hospital, Toronto ON Canada
  • Jessica McAlpine · STUDY_CHAIR · BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Who to contact

Wendy Parulekar
[email protected]
613-533-6430
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status3 years