Tailoring Therapy in Post-surgical Patients With Low-risk Endometrial Cancer

May 15, 2025 updated by: NRG Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Estimate the rate of pelvic recurrence at 3 years in patients who are treated with a de-escalated adjuvant treatment directed by tumour molecular status.

SECONDARY OBJECTIVES:

I. Estimate the rate of isolated vaginal recurrence, para-aortic recurrence and distant metastasis at 3 years.

II. Estimate the recurrence-free, endometrial cancer-specific and overall survival.

III. Describe the impact of molecular classification on patient decisional conflict and fear of recurrence.

TERTIARY OBJECTIVES:

I. Evaluate health economic impact of molecular classification-tailored adjuvant therapy on the cost of treating endometrial cancer.

II. Evaluate quality of life. III. Determine if variability in adjuvant treatment given to patients with endometrial cancer is decreased by molecular classification-tailored adjuvant therapy as compared to recent clinical practice data.

IV. To assess if additional molecular parameters can further refine prognosis within POLE-mutated and p53wt/no specific molecular profile (NSMP) endometrial cancer (EC).

OUTLINE: Patients are assigned to 1 of 2 sub-studies.

SUB-STUDY A: Patients are assigned to 1 of 2 cohorts.

COHORT A1: Patients with POLE-mutated early-stage EC undergo observation on study.

COHORT A2: Patients with higher-risk POLE-mutated EC undergo observation or external beam radiation therapy (EBRT) and/or vaginal brachytherapy over 3-5 fractions.

SUB-STUDY B: Patients with p53 wildtype/NSMP ER+ EC undergo observation or vaginal brachytherapy over 3-5 fractions.

All patients undergo chest x-ray and computed tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET)/CT scans during screening and as clinically indicated throughout the trial.

After completion of study treatment, patients are followed up at 3 and 6 months, then every 6 months for 3 years, and then every year.

Study Type

Interventional

Enrollment (Estimated)

325

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • Centro Comprensivo de Cancer de UPR
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Marina D. Miller
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Marina D. Miller
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • University of Arizona Cancer Center-Orange Grove Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 520-694-8900
        • Principal Investigator:
          • Marina D. Miller
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • Bobbie J. Rimel
        • Contact:
          • Site Public Contact
          • Phone Number: 310-423-8965
      • Pasadena, California, United States, 91105
        • Recruiting
        • Huntington Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 626-535-2420
        • Principal Investigator:
          • Bobbie J. Rimel
      • Sacramento, California, United States, 95816
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Bradley R. Corr
    • Florida
      • N. Venice, Florida, United States, 34275
        • Recruiting
        • Sarasota Memorial Hospital-Venice
        • Principal Investigator:
          • Beverly Long
        • Contact:
          • Site Public Contact
          • Phone Number: 941-261-9000
      • Sarasota, Florida, United States, 34236
        • Recruiting
        • Florida Cancer Specialists - Sarasota Downtown
        • Principal Investigator:
          • Beverly Long
        • Contact:
          • Site Public Contact
          • Phone Number: 941-957-1000
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Principal Investigator:
          • Beverly Long
        • Contact:
          • Site Public Contact
          • Phone Number: 941-917-2225
      • Sarasota, Florida, United States, 34243
        • Recruiting
        • Sarasota Memorial Health Care Center at University Parkway
        • Principal Investigator:
          • Beverly Long
        • Contact:
          • Site Public Contact
          • Phone Number: 941-917-6519
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • First Physicians Group-Sarasota
        • Principal Investigator:
          • Beverly Long
        • Contact:
          • Site Public Contact
          • Phone Number: 941-917-8383
      • Venice, Florida, United States, 34275
        • Recruiting
        • Florida Cancer Specialists - Venice Pinebrook
        • Contact:
        • Principal Investigator:
          • Beverly Long
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Jill Remick
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Jill Remick
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Jill Remick
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Jill Remick
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
        • Principal Investigator:
          • Leda Portia A. Gattoc
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Dario R. Roque
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Dario R. Roque
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Ascension Saint Vincent Indianapolis Hospital
        • Contact:
        • Principal Investigator:
          • Megan E. Buechel
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Tara Castellano
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Active, not recruiting
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Recruiting
        • UMass Memorial Medical Center - Memorial Division
        • Contact:
          • Site Public Contact
          • Phone Number: 508-856-6265
        • Principal Investigator:
          • Susan L. Zweizig
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Saint Vincent Frontier Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-648-6274
        • Principal Investigator:
          • Megan Petersen
      • Billings, Montana, United States, 59106
        • Recruiting
        • Intermountain Health West End Clinic
        • Contact:
          • Site Public Contact
          • Phone Number: 406-238-6685
        • Principal Investigator:
          • Megan Petersen
    • New Jersey
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Sidney Kimmel Cancer Center Washington Township
        • Contact:
        • Principal Investigator:
          • Mitchell I. Edelson
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Active, not recruiting
        • University of New Mexico Cancer Center
    • New York
      • New York, New York, United States, 10011
        • Recruiting
        • Mount Sinai Chelsea
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Caitlin Carr
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 212-824-7309
          • Email: CCTO@mssm.edu
        • Principal Investigator:
          • Caitlin Carr
      • Oswego, New York, United States, 13126
        • Recruiting
        • Upstate Cancer Center Radiation Oncology at Oswego
        • Contact:
        • Principal Investigator:
          • Mary J. Cunningham
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Mary J. Cunningham
      • Verona, New York, United States, 13478
        • Recruiting
        • Upstate Cancer Center at Verona
        • Contact:
        • Principal Investigator:
          • Mary J. Cunningham
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Olivia D. Lara
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Duke Women's Cancer Care Raleigh
        • Principal Investigator:
          • Angeles A. Secord
        • Contact:
          • Site Public Contact
          • Phone Number: 919-785-4878
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Casey Cosgrove
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Christina Washington
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Shaina Bruce
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Mitchell I. Edelson
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Mitchell I. Edelson
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital
        • Principal Investigator:
          • Matthew T. Oliver
        • Contact:
          • Site Public Contact
          • Phone Number: 401-274-1122
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Principal Investigator:
          • Ann H. Klopp
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Ann H. Klopp
        • Contact:
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Principal Investigator:
          • Ann H. Klopp
        • Contact:
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Principal Investigator:
          • Ann H. Klopp
        • Contact:
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Principal Investigator:
          • Ann H. Klopp
        • Contact:
    • Utah
      • Farmington, Utah, United States, 84025
        • Recruiting
        • Farmington Health Center
        • Contact:
        • Principal Investigator:
          • Cristina DeCesaris
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • University of Utah Sugarhouse Health Center
        • Contact:
        • Principal Investigator:
          • Cristina DeCesaris
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Cristina DeCesaris
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Contact:
        • Principal Investigator:
          • Emma C. Fields
    • Washington
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • William H. Bradley

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: X-Ray Imaging
Undergo x-ray imaging
Other Names:
  • Conventional X-Ray
  • Diagnostic Radiology
  • Medical Imaging, X-Ray
  • Radiographic Imaging
  • Radiography
  • RG
  • Static X-Ray
  • X-Ray
  • Plain film radiographs
  • Radiographic imaging procedure (procedure)
Other: Clinical Observation
Undergo observation
Other Names:
  • observation
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: X-Ray Imaging
Undergo x-ray imaging
Other Names:
  • Conventional X-Ray
  • Diagnostic Radiology
  • Medical Imaging, X-Ray
  • Radiographic Imaging
  • Radiography
  • RG
  • Static X-Ray
  • X-Ray
  • Plain film radiographs
  • Radiographic imaging procedure (procedure)
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • EBRT
  • Definitive Radiation Therapy
  • External Beam Radiation
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
  • Radiation, External Beam
  • Teleradiotherapy
  • Teletherapy
  • Teletherapy Radiation
  • External Beam Radiotherapy (conventional)
Other: Clinical Observation
Undergo observation
Other Names:
  • observation
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: High-Dose-Rate Vaginal Brachytherapy
Undergo vaginal brachytherapy
Other Names:
  • HDR-IVB
  • High-Dose-Rate Intra-Vaginal Brachytherapy
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: X-Ray Imaging
Undergo x-ray imaging
Other Names:
  • Conventional X-Ray
  • Diagnostic Radiology
  • Medical Imaging, X-Ray
  • Radiographic Imaging
  • Radiography
  • RG
  • Static X-Ray
  • X-Ray
  • Plain film radiographs
  • Radiographic imaging procedure (procedure)
Other: Clinical Observation
Undergo observation
Other Names:
  • observation
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Computed Tomography
Undergo CT or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: High-Dose-Rate Vaginal Brachytherapy
Undergo vaginal brachytherapy
Other Names:
  • HDR-IVB
  • High-Dose-Rate Intra-Vaginal Brachytherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will include disease recurrence in the vagina, post-operative bed and pelvic lymph nodes. Histological evidence of recurrence in the vagina will be required. For pelvic nodal recurrence, the suspicious lymph node(s) should measure >= 10 mm in short axis and be confirmed with at least 2 methods (e.g. histological and radiological; or 2 different imaging modalities such as computed tomography and fludeoxyglucose F 18 positron emission tomography or magnetic resonance imaging; or evidence of lymph node growth on 2 imaging exams at least 2 months apart). All recurrences will be reviewed by a central adjudication committee. Distant metastasis and death in absence of pelvic failure will be considered competing risk events in the analysis of this endpoint. Subjects without any of the listed events (i.e. events of interest or competing risks events) are censored at the date of the most recent follow-up examination.
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
Distant metastasis and death in absence of vaginal failure will be considered competing risk events in the analysis.
Time from enrollment to the time of histologic confirmation of vaginal recurrence, 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
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
Time from enrollment to the time of death from endometrial cancer, assessed up to 2 years
Fear of recurrence
Time Frame: Up to 2 years
All patients who have completed the Fear of Recurrence Inventory are evaluable for fear of recurrence.
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
Distant metastasis and death in absence of para-aortic recurrence will be considered competing risk events in the analysis.
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
Distant recurrence includes all tumour recurrences at distant sites, such as supraclavicular and/or mediastinal nodes, peritoneal carcinomatosis, malignant ascites, metastasis in liver, lung, bone, brain and/or other distant sites. Death in absence of distant metastasis will be considered a competing risk event in the analysis.
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
Overall survival
Time Frame: Time from enrollment to the time of death from any cause, assessed up to 2 years
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
All patients who have completed baseline and at least 1 follow-up QOL questionnaire are evaluable for QOL.
Up to 2 years
Health economics
Time Frame: Up to 2 years
All enrolled patients are evaluable for health economics evaluation. Those who have completed the health utility questionnaire and for whom resource utilization data are measured, will be evaluable for the economic analysis
Up to 2 years
Decisional conflict
Time Frame: Up to 2 years
All patients who have completed the Decisional Conflict Scale are evaluable for decisional conflict. Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after molecular classification.
Up to 2 years
Incidence of adverse events
Time Frame: Up to 2 years
All patients will be evaluable for adverse event evaluation from the time of enrollment. Toxicity will be scored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and will assess risks of gastrointestinal, genitourinary, musculoskeletal and vaginal toxicity.
Up to 2 years
Variability in adjuvant treatment
Time Frame: Up to 2 years
Treatment variation is defined as the proportion of cases enrolled where adjuvant therapy administered deviated from the recommendations.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to isolated vaginal recurrence
Time Frame: Time from enrollment to the time of histologic confirmation of vaginal recurrence, assessed up to 2 years
Distant metastasis and death in absence of vaginal failure will be considered competing risk events in the analysis.
Time from enrollment to the time of histologic confirmation of vaginal recurrence, assessed up to 2 years
Fear of recurrence
Time Frame: Up to 2 years
All patients who have completed the Fear of Recurrence Inventory are evaluable for fear of recurrence.
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
Recurrence-free survival
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
Endometrial cancer-specific survival
Time from enrollment to the time of death from endometrial cancer, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Matthew A Powell, NRG Oncology

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 Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

January 16, 2027

Study Completion (Estimated)

January 16, 2027

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 15, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-GY032 (Other Identifier: NRG)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2023-09355 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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