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

NCT04386993 | Completed DMC FDA Device

• 1 other identifier: 202004237
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE

  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

  Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation

• Change in quality of life as measured by FACT-En

  Baseline, 2 weeks, 3 months, 6 months, and 12 months post-completion of radiation

• Locoregional control

  Up to 12 months post-completion of radiation

• Distant control

  Up to 12 months post-completion of radiation

Study Arms (1)

IMRT

EXPERIMENTAL

-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

Interventions

Intensity modulated radiation therapy RADIATION

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

Also known as: IMRT

IMRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Jessika Contreras, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: July 7, 2020
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Proposals may be submitted up to 36 months following article publication.
• Access Criteria: Please contact Dr. Jessika Contreras.

Locations

US (1)