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

Overview

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.

Full Title of Study: “De-escalated Conformal Radiation Expedited Sequentially With Chemotherapy for Endometrial Cancer (DeCRESCEndo)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2023

Interventions

  • Radiation: Intensity modulated radiation therapy
    • Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events
    • Time Frame: From start of radiation until 2 weeks after completion of radiation (approximately 4 weeks)
  • Incidence of late hematologic, gastrointestinal, and genitourinary adverse events
    • Time Frame: From 2 weeks after completion of radiation until 12 months (approximately 50 weeks)

Secondary Measures

  • Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE
    • Time Frame: Baseline, 2 weeks, and 3 months post-completion of radiation
    • 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
  • Change in patient-reported urinary and gastrointestinal toxicity as measured by bowel/bladder domains of EPIC-26
    • Time Frame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
    • 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.
  • Change in quality of life as measured by FACT-En
    • Time Frame: Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation
    • 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.
  • Locoregional control
    • Time Frame: Up to 12 months post-completion of radiation
    • -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.
  • Distant control
    • Time Frame: Up to 12 months post-completion of radiation
    • -Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.
  • Disease-free survival
    • Time Frame: Up to 12 months post-completion of radiation
    • -Disease-free survival is defined as no evidence of endometrial cancer recurrence or death
  • Overall survival
    • Time Frame: Up to 12 months post-completion of radiation
    • -Number of participants alive at the time of completion of follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • Histologically or cytologically confirmed stage IIIA-IV endometrial cancer, or any stage with uterine serous 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 K/cumm
  • Absolute neutrophil count ≥ 500 K/cumm
  • Platelets ≥ 50,000 K/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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Perry Grigsby, M.D., Principal Investigator, Washington University School of Medicine
  • Overall Contact(s)
    • Perry Grigsby, M.D., 314-362-8502, pgrigsby@wustl.edu

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