RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-12-19

Study Completion:2029-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05640999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis. * Prior pelvic radiation. * Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid 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) (

Inclusion Criteria

Exclusion 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

* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid 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) (

Contacts and Locations

Study Contact

Wendy Parulekar

CONTACT

613-533-6430

wparulekar@ctg.queensu.ca

Principal Investigator

Kathy Han

STUDY_CHAIR

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Jessica McAlpine

STUDY_CHAIR

BCCA-Vancouver Cancer Centre, Vancouver BC Canada

Study Locations (Sites)

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

UMass Memorial Medical Centre

Worcester, Massachusetts, 01605

United States

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, 08080

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

University of Utah Sugarhouse Health Centre

Salt Lake City, Utah, 84106

United States

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Canadian Cancer Trials Group

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-19

Study Completion Date2029-06-30

Study Record Updates

Study Start Date2022-12-19

Study Completion Date2029-06-30

Terms related to this study

Additional Relevant MeSH Terms

Endometrial Cancer