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

Phase 1

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Radiation: Intensity modulated radiation therapy

• Registration Number: NCT04386993
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-13
• Study Start: 2020-07-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-26
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT	Intensity modulated radiation therapy	-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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in patient-reported urinary and gastrointestinal toxicity as measured by PRO-CTCAE	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 quality of life as measured by FACT-En	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.
Distant control	Up to 12 months post-completion of radiation	-Distant recurrence is defined as histologic or radiographic evidence of cancer outside of the radiated field.
Overall survival	Up to 12 months post-completion of radiation	-Number of participants alive at the time of completion of follow-up
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	* 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.
Locoregional control	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.
Disease-free survival	Up to 12 months post-completion of radiation	-Disease-free survival is defined as survival with no evidence of disease recurrence or death

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States