Recruiting
Phase 2

Tailoring Therapy

Sponsor:

NRG Oncology

Code:

NCT06388018

Conditions

Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinical Observation

Computed Tomography

External Beam Radiation Therapy

High-Dose-Rate Vaginal Brachytherapy

Magnetic Resonance Imaging

Study Details

Brief summary:

This phase II trial tests how well tailoring therapy in post-surgery works in patients with low-risk endometrial cancer. The usual approach for patients with low-risk endometrial cancer is treatment with surgery. In this study, tissue that is removed as part of the surgical procedure is analyzed in the pathology laboratory to help guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Conditions

Stage I Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Stage II Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Stage III Uterine Corpus Endometrial Stromal Sarcoma AJCC v8

Study ID

NCT06388018

Start date

Jan 27, 2025

Status verified date

May, 2025

Completion date

Jan 16, 2027

Anticipated

Primary completion date

Jan 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy). 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
  • Patients' age must be >= 18 years
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group's procedures
  • 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. The baseline assessment must be completed within required timelines, prior to enrollment. Inability (lack of comprehension in English or French, or other equivalent reason such as cognitive issues or lack of competency) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible
  • Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits placed on patients being considered for this trial. The patient's city of residence may be required to verify their geographical proximity. (Call the CCTG office (613-533-6430) if questions arise regarding the interpretation of this criterion.) Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
  • Patients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial
  • Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
  • SUB-STUDY A: Patients with endometrial carcinoma (endometrioid, serous, clear cell, un-/dedifferentiated, carcinosarcoma, mixed), must have one of the following combinations of International Federation of Gynecology and Obstetrics (FIGO) stage, grade, and lymphovascular invasion (LVI):

  • Cohort A1:

  • Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.)
  • Stage IB, grade 1 or 2, pNx/N0, with or without LVI
  • Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.)
  • Stage II (microscopic), grade 1 or 2, pN0, without substantial LVI (Pelvic lymph node surgical assessment (sentinel or full lymphadenectomy) is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated.) (Substantial LVI is defined as >= 3 foci per College of American Pathologists' reporting guideline)
  • Cohort A2:

  • Stage IA (not confined to polyp), grade 3, pNx, with or without LVI
  • Stage IB, grade 3, pNx, with or without LVI
  • Stage IB, grade 3, pN0, with substantial LVI (Substantial LVI is defined as >= 3 foci per College of American Pathologists' reporting guideline)
  • Stage II (microscopic), grade 1 or 2, pNx, with or without LVI
  • Stage II (microscopic), grade 1 or 2, pN0, with substantial LVIƒõ
  • Stage II (microscopic), grade 3, pNx/N0, with or without LVI
  • Stage II non-microscopic, any grade, pNx/N0, with or without LVI
  • Stage III, any grade, pNx/N0-2, with or without LVI
  • Substantial LVI is defined as .3 foci per College of American Pathologists¡¦ reporting guideline
  • SUB-STUDY A: Patients must have a molecular classification of POLE mutation.

  • Note: patients in Cohort A2 should have a known POLE pathogenic mutation prior to consenting
  • SUB-STUDY B: Patients with endometrial carcinoma (endometrioid only), must have one of the following combinations of FIGO stage, grade, and lymphovascular invasion (LVI):

  • Stage IA (not confined to polyp), grade 3, pN0, with or without LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as >= 3 foci per College of American Pathologists' reporting guideline)
  • Stage IB, grade 1 or 2, pNx/N0, with or without LVI
  • Stage IB, grade 3, pN0, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as >= 3 foci per College of American Pathologists' reporting guideline)
  • Stage II (microscopic), grade 1 or 2, pN0\*, without substantial LVI (Pelvic lymph node surgical assessment \[sentinel or full lymphadenectomy\] is required for grade 3 or stage II. Para-aortic lymphadenectomy is not mandated) (Substantial LVI is defined as >= 3 foci per College of American Pathologists' reporting guideline)
  • SUB-STUDY B: Patients must have molecular classification of p53wt/NSMP (based on normal p53 IHC, and absence of pathogenic POLE mutation or MMR deficiency)
  • SUB-STUDY B: Estrogen receptor positive (> 10% of the tumour with positive nuclear staining) on IHC

Exclusion Criteria:

  • 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)
  • SUB-STUDY A: Isolated tumour cell(s) identified in lymph node(s) for patients in Cohort A1
  • SUB-STUDY B: Abnormal p53 and/or mismatch repair deficiency on immunohistochemistry without pathogenic POLE mutation.

  • Abnormal p53 can also be determined by TP53 mutations found on DNA testing.
  • SUB-STUDY B: p53wt/NSMP endometrial carcinoma with a MELF (microcystic, elongated and fragmented) pattern of myoinvasion and/or substantial lymphovascular invasion
  • SUB-STUDY B: Stage IA (not confined to polyp), grade 3, pN0, with substantial LVI. Stage IB, grade 1 or 2, pNx/N0, with substantial LVI
  • SUB-STUDY B: Isolated tumour cell(s) identified in lymph node(s)

Study Design

Enrollment

325 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cohort A1

Patients with POLE-mutated early-stage EC undergo observation on study. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

experimental: Cohort A2

Patients with higher-risk POLE-mutated EC undergo observation or EBRT and/or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

active comparator: Sub-study B

Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions. Patients undergo chest x-ray and CT or MRI or PET/CT scans during screening and as clinically indicated throughout the trial.

Interventions

Clinical Observation

Undergo observation

Computed Tomography

Undergo CT or PET/CT

External Beam Radiation Therapy

Undergo EBRT

High-Dose-Rate Vaginal Brachytherapy

Undergo vaginal brachytherapy

Magnetic Resonance Imaging

Undergo MRI

Positron Emission Tomography

Undergo PET/CT

Questionnaire Administration

Ancillary studies

X-Ray Imaging

Undergo x-ray imaging

Primary outcome measure

  • Time to pelvic recurrence [ Time Frame: Time from enrollment to the time of recurrent disease within the pelvis (including the vagina), assessed up to 2 years ]
  • Time to isolated vaginal recurrence [ Time Frame: Time from enrollment to the time of histologic confirmation of vaginal recurrence, assessed up to 2 years ]
  • Time to para-aortic recurrence [ Time Frame: Time from enrollment to the time of radiological and/or histologic confirmation of para-aortic recurrence (i.e. nodal recurrence at/above L5/S1 and below the renal hilum), whichever occurs first, assessed up to 2 years ]
  • Time to distant metastasis [ Time Frame: Time from enrollment to the time of radiological and/or histologic confirmation of para-aortic recurrence (i.e. nodal recurrence at/above L5/S1 and below the renal hilum), whichever occurs first, assessed up to 2 years ]
  • Recurrence-free survival [ Time Frame: Time from enrollment to the time of endometrial cancer recurrence or death, whichever occurs first, assessed up to 2 years ]
  • Endometrial cancer-specific survival [ Time Frame: Time from enrollment to the time of death from endometrial cancer, assessed up to 2 years ]
  • Overall survival [ Time Frame: Time from enrollment to the time of death from any cause, assessed up to 2 years ]
  • Quality of life (QOL) [ Time Frame: Up to 2 years ]
  • Health economics [ Time Frame: Up to 2 years ]
  • Decisional conflict [ Time Frame: Up to 2 years ]
  • Fear of recurrence [ Time Frame: Up to 2 years ]
  • Incidence of adverse events [ Time Frame: Up to 2 years ]
  • Variability in adjuvant treatment [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Alaska Women's Cancer Care

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Site Public Contact

907-212-6871AKPAMC.OncologyResearchSupport@providence.org

Principal Investigator:

Dan S. Zuckerman

University of Arizona Cancer Center-Orange Grove Campus

Recruiting

Tucson, Arizona, United States, 85704

Contacts

Site Public Contact

520-694-8900

Principal Investigator:

Marina D. Miller

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Marina D. Miller

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Marina D. Miller

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Site Public Contact

310-423-8965

Principal Investigator:

Bobbie J. Rimel

Huntington Memorial Hospital

Recruiting

Pasadena, California, United States, 91105

Contacts

Site Public Contact

626-535-2420

Principal Investigator:

Bobbie J. Rimel

Sutter Medical Center Sacramento

Recruiting

Sacramento, California, United States, 95816

Contacts

Site Public Contact

clinicalresearch@sutterhealth.org

Principal Investigator:

Christopher U. Jones

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Bradley R. Corr

Sarasota Memorial Hospital-Venice

Recruiting

N. Venice, Florida, United States, 34275

Contacts

Site Public Contact

941-261-9000

Principal Investigator:

Beverly Long

Florida Cancer Specialists - Sarasota Downtown

Recruiting

Sarasota, Florida, United States, 34236

Contacts

Site Public Contact

941-957-1000

Principal Investigator:

Beverly Long

First Physicians Group-Sarasota

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Site Public Contact

941-917-8383

Principal Investigator:

Beverly Long

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Site Public Contact

941-917-2225

Principal Investigator:

Beverly Long

Sarasota Memorial Health Care Center at University Parkway

Recruiting

Sarasota, Florida, United States, 34243

Contacts

Site Public Contact

941-917-6519

Principal Investigator:

Beverly Long

Florida Cancer Specialists - Venice Pinebrook

Recruiting

Venice, Florida, United States, 34275

Contacts

Site Public Contact

239-274-9930ClinicalTrials@FLCancer.com

Principal Investigator:

Beverly Long

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jill Remick

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Jill Remick

Piedmont Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Site Public Contact

404-425-7943ORS@piedmont.org

Principal Investigator:

Leda Portia A. Gattoc

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Jill Remick

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Jill Remick

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Dario R. Roque

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Site Public Contact

217-528-7541pallante.beth@mhsil.com

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Site Public Contact

630-352-5360Donald.Smith3@nm.org

Principal Investigator:

Dario R. Roque

Ascension Saint Vincent Indianapolis Hospital

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Site Public Contact

317-338-2194research@stvincent.org

Principal Investigator:

Megan E. Buechel

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

UMass Memorial Medical Center - Memorial Division

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

Site Public Contact

508-856-6265

Principal Investigator:

Susan L. Zweizig

Saint Vincent Frontier Cancer Center

Recruiting

Billings, Montana, United States, 59102

Contacts

Site Public Contact

800-648-6274

Principal Investigator:

Megan Petersen

Intermountain Health West End Clinic

Recruiting

Billings, Montana, United States, 59106

Contacts

Site Public Contact

406-238-6685

Principal Investigator:

Megan Petersen

Sidney Kimmel Cancer Center Washington Township

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Mitchell I. Edelson

Mount Sinai Chelsea

Recruiting

New York, New York, United States, 10011

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Caitlin Carr

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Caitlin Carr

Upstate Cancer Center Radiation Oncology at Oswego

Recruiting

Oswego, New York, United States, 13126

Contacts

Site Public Contact

315-464-3603BinghamE@upstate.edu

Principal Investigator:

Mary J. Cunningham

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Mary J. Cunningham

Upstate Cancer Center at Verona

Recruiting

Verona, New York, United States, 13478

Contacts

Site Public Contact

315-464-8230McDowelE@upstate.edu

Principal Investigator:

Mary J. Cunningham

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Olivia D. Lara

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Angeles A. Secord

Duke Women's Cancer Care Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Site Public Contact

919-785-4878

Principal Investigator:

Angeles A. Secord

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Casey Cosgrove

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Christina Washington

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Shaina Bruce

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Mitchell I. Edelson

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Mitchell I. Edelson

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Site Public Contact

401-274-1122

Principal Investigator:

Matthew T. Oliver

MD Anderson in The Woodlands

Recruiting

Conroe, Texas, United States, 77384

Contacts

Site Public Contact

866-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Ann H. Klopp

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

877-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Ann H. Klopp

MD Anderson West Houston

Recruiting

Houston, Texas, United States, 77079

Contacts

Site Public Contact

877-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Ann H. Klopp

MD Anderson League City

Recruiting

League City, Texas, United States, 77573

Contacts

Site Public Contact

877-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Ann H. Klopp

MD Anderson in Sugar Land

Recruiting

Sugar Land, Texas, United States, 77478

Contacts

Site Public Contact

877-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Ann H. Klopp

Farmington Health Center

Recruiting

Farmington, Utah, United States, 84025

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Cristina DeCesaris

University of Utah Sugarhouse Health Center

Recruiting

Salt Lake City, Utah, United States, 84106

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Cristina DeCesaris

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Site Public Contact

888-424-2100cancerinfo@hci.utah.edu

Principal Investigator:

Cristina DeCesaris

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Kara Romano

Virginia Commonwealth University/Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

CTOclinops@vcu.edu

Principal Investigator:

Emma C. Fields

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Site Public Contact

206-215-3086PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Site Public Contact

206-215-3086PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-3086PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

William H. Bradley

More Information

Sponsor

NRG Oncology

Last update posted

May 20, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NRG Oncology on 2025-05-20.