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Completed

NCT Number: NCT04386993

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity modulated radiation therapy

Radiation

Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).

Other names: IMRT

Primary outcomes

  1. Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events

    Time frame: From start of radiation through Day 90

  2. Incidence of late hematologic, gastrointestinal, and genitourinary adverse events

    Time frame: From Day 91 through month 12

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Disease-free survival

    Time frame: Up to 12 months post-completion of radiation

    -Disease-free survival is defined as survival with no evidence of disease recurrence or death

  7. Overall survival

    Time frame: Up to 12 months post-completion of radiation

    -Number of participants alive at the time of completion of follow-up

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: DeCRESCEndo

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 13, 2020
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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