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

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

Conditions

Endometrial Cancer

Study Overview

Study Details

Study overview

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

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

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

Condition
Endometrial Cancer
Intervention / Treatment

-

Contacts and Locations

Aurora

UCHealth University of Colorado Hospital, Aurora, Colorado, United States, 80045

Worcester

UMass Memorial Medical Centre, Worcester, Massachusetts, United States, 01605

Sewell

Sidney Kimmel Cancer Center Washington Township, Sewell, New Jersey, United States, 08080

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73104

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Willow Grove

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States, 19090

Providence

Women and Infants Hospital, Providence, Rhode Island, United States, 02905

Salt Lake City

University of Utah Sugarhouse Health Centre, Salt Lake City, Utah, United States, 84106

Salt Lake City

Huntsman Cancer Institute University of Utah, Salt Lake City, Utah, United States, 84112

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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) (

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-06-30