De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)

De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)

The goal of this study is to evaluate short course radiation in the post-operative female pelvis after hysterectomy in stage III-IVA endometrial adenocarcinoma patients, or any stage patients with uterine serous or carcinosarcoma histology. The investigators hypothesize that short course pelvic radiation will have an acute and late grade 3-4 toxicity rate < 10%, and patients will benefit from both convenient and effective loco-regional control comparable to the traditional 5-6 weeks of radiation.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Radiation: Intensity modulated radiation therapy

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jessika Contreras, M.D.; Phone Number: 314-747-7236; Email: jcontreras@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Andrea Hagemann, M.D.
      • Sub-Investigator: Julie Schwarz, M.D., Ph.D.
      • Sub-Investigator: Yi Huang, M.S.
      • Contact: Jessika Contreras, M.D.; Phone Number: 314-747-7236; Email: jcontreras@wustl.edu
      • Principal Investigator: Jessika Contreras, M.D.
      • Sub-Investigator: Stephanie Markovina, M.D., Ph.D.
      • Sub-Investigator: Matthew Powell, M.D.
      • Sub-Investigator: Lindsay Kuroki, M.D.
      • Sub-Investigator: L. Stewart Massad, M.D.
      • Sub-Investigator: Carolyn McCourt, M.D.
      • Sub-Investigator: David Mutch, M.D.
      • Sub-Investigator: Premal Thaker, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically or cytologically confirmed stage IIIA-IVA endometrial cancer, or any stage I-IVA where any proportion of the tumor is uterine serous, clear cell, de-differentiated, or carcinosarcoma histology.
• Must have already undergone radical hysterectomy. Hysterectomy may have occurred no more than one year prior to enrollment.
• At least 18 years of age.
• ECOG performance status ≤ 2

• Minimal bone marrow and organ function as defined below:

  • Leukocytes ≥ 1,000 cumm
  • Absolute neutrophil count ≥ 500 cumm
  • Platelets ≥ 50,000 cumm
  • Hemoglobin ≥ 7g/dL
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

• Prior radiation to the pelvis.
• Currently receiving any investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, inflammatory bowel disease, or irritable bowel disease.
• Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMRT; -Five 5-Gy fractions of IMRT will be given to the pelvis with elective simultaneous boost to any suspicious lymph node or residual disease to 30 Gy. -*Brachytherapy boost (at the discretion of the PI) within 2 weeks of radiation therapy completion. Once or twice weekly for three weeks	Radiation: Intensity modulated radiation therapy; Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).; Other Names: IMRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events	From start of radiation through Day 90
Incidence of late hematologic, gastrointestinal, and genitourinary adverse events	From Day 91 through month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE	PRO-CTCAE responses are scored from 0 to 4 with 0=Never/Not at all/None and 4=Frequently/Very Much/Very Severe/Almost Constantly; Scores for each attribute (frequency, severity and/or interference) will be presented descriptively	Baseline, 2 weeks, and 3 months post-completion of radiation
Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26	Bladder has 7 questions and bowel has 9 questions; The response for each item is standardized to a 0 to 100 scale; The standardized values will be averaged for all items within a group to create the summary or subscale score.	Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Change in quality of life as measured by FACT-En	Questionnaire asking questions about physical well-being, social/family well-being, emotional well-being, functional well-being, and other additional concerns. Answers range from 0 = not at all to 4 = very much. Questions are phrased so that higher numbers indicate a better health state,; Scoring is performed through a simple sum of item scores. Each subscale is scored, and a total score is obtained by adding each of the subscale scores.	Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
Locoregional control	-Locoregional recurrence is defined as histologic or radiographic evidence of cancer in the previously resected site or regional lymph nodes included in the radiated field.	Up to 12 months post-completion of radiation
Distant control	-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.	Up to 12 months post-completion of radiation
Overall survival	-Number of participants alive at the time of completion of follow-up	Up to 12 months post-completion of radiation
Disease-free survival	-Disease-free survival is defined as survival with no evidence of disease recurrence or death	Up to 12 months post-completion of radiation

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Jessika Contreras, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: 202004237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) for individual participant data meta-analysis by investigators whose proposed use of data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
• IPD Sharing Time Frame: Proposals may be submitted up to 36 months following article publication.
• IPD Sharing Access Criteria: Please contact Dr. Alexander Lin at alexanderlin@wustl.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No