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Adjuvant Therapy in POLE-Muta...

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

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2029-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Endometrial Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sub-study A: RAINBO BLUE Cohort A1

Observation

Group Type EXPERIMENTAL

Observation

Intervention Type OTHER

Observation

Sub-Study A: RAINBO BLUE Cohort A2

Observation or Adjuvant Radiotherapy

Group Type EXPERIMENTAL

Adjuvant radiotherapy (EBRT +/- brachytherapy)

Intervention Type 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.

Observation

Intervention Type OTHER

Observation

Sub-Study B: TAPER

Observation or Vaginal Brachytherapy

Group Type EXPERIMENTAL

Vaginal brachytherapy

Intervention Type RADIATION

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

Observation

Intervention Type OTHER

Observation

Interventions

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Vaginal brachytherapy

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

Intervention Type RADIATION

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.

Intervention Type RADIATION

Observation

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathy Han

Role: STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Jessica McAlpine

Role: STUDY_CHAIR

BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Locations

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Alaska Womens Cancer Care

Anchorage, Alaska, United States

Site Status RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Huntington Memorial Hospital

Pasadena, California, United States

Site Status RECRUITING

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Sarasota Memorial Hospital - Venice

N. Venice, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States

Site Status RECRUITING

First Physicians Group-Sarasota

Sarasota, Florida, United States

Site Status RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status RECRUITING

Sarasota Memorial Health Care Centre

Sarasota, Florida, United States

Site Status RECRUITING