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

Washington University School of Medicine25 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Endometrial Cancer

Interventions

Intensity modulated radiation therapyRADIATION

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Incidence of acute hematologic, gastrointestinal, and genitourinary adverse events

Time frame: From start of radiation through Day 90

Incidence of late hematologic, gastrointestinal, and genitourinary adverse events

Time frame: From Day 91 through month 12

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

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

Locoregional control

Data from ClinicalTrials.gov

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