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New treatment approach for early-stage endometrial cancer with specific genetic profiles

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

Phase 2 Interventional Canadian Cancer Trials Group · NCT05640999

This study is testing a new treatment plan for early-stage endometrial cancer patients with specific genetic profiles to see if it works better than the usual treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment393 (estimated)
Ages18 Years and up
SexFemale
SponsorCanadian Cancer Trials Group Research network
Drugs / interventionschemotherapy, radiation
Locations108 sites (Anchorage, Alaska and 107 other locations)
Trial IDNCT05640999 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a de-escalated adjuvant treatment strategy for patients with early-stage endometrial cancer who have either POLE mutations or p53 wildtype/NSMP profiles. Participants will be enrolled in one of two sub-studies, focusing on the effectiveness of vaginal brachytherapy, adjuvant radiotherapy, or observation compared to standard treatment protocols. The goal is to determine if this new approach offers better outcomes than the conventional methods typically used for this type of cancer.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed Stage I to III endometrial carcinoma who have undergone surgery and have no residual disease.

Not a fit: Patients with advanced-stage endometrial cancer or those who have not undergone the required surgical procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients with specific genetic profiles of endometrial cancer.

How similar studies have performed: Other studies have shown promise in using targeted therapies for specific genetic profiles in cancer treatment, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anchorage, Alaska and 107 other locations

+58 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.