RecruitingPhase 2NCT05640999

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)

Sponsor

Canadian Cancer Trials Group

Enrollment

393 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating the best type of additional treatment (called adjuvant therapy) after surgery for women with early-stage endometrial (uterine) cancer that has specific genetic markers — either a POLE mutation (which is associated with a good outlook) or a p53-wildtype/NSMP profile. **You may be eligible if...** - You have had a hysterectomy and removal of both ovaries for confirmed Stage I–III endometrial cancer - There is no visible remaining cancer after surgery - Your cancer has been tested for specific genetic markers (POLE mutation or p53/NSMP status) - You are 18 years or older and in acceptable general health (ECOG 0–2) - If you have HIV, your viral load is undetectable on treatment **You may NOT be eligible if...** - Cancer remains after surgery - Your cancer is a different subtype not covered by the study's molecular categories - Your organ function is too poor for study treatments - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(105)

Alaska Womens Cancer Care

Anchorage, Alaska, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

University of Miami School of Medicine

Miami, Florida, United States

Sarasota Memorial Hospital - Venice

N. Venice, Florida, United States

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States

First Physicians Group-Sarasota

Sarasota, Florida, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Sarasota Memorial Health Care Centre

Sarasota, Florida, United States

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, United States

Grady Health System