Standard Versus Intensity-Modulated Pelvic Radiation Therapy in Treating Patients With Endometrial or Cervical Cancer
- Conditions
- Perioperative/Postoperative ComplicationsGastrointestinal ComplicationsCervical CancerEndometrial CancerRadiation ToxicityUrinary Tract ToxicityUrinary Complications
- Interventions
- Radiation: intensity-modulated radiation therapyRadiation: Standard radiation therapy
- Registration Number
- NCT01672892
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
- Detailed Description
OBJECTIVES:
Primary
* To determine if pelvic intensity-modulated radiation therapy (IMRT) reduces acute gastrointestinal toxicity in the 5th week (after 23-25 fractions) of pelvic radiation as measured with the expanded prostate cancer index composite (EPIC) instrument.
Secondary
* To determine if grade 2+ gastrointestinal toxicity (Common Terminology Criteria for Adverse Events version 4.0 \[CTCAE v. 4.0\]) is reduced with IMRT compared to conventional whole-pelvis radiation therapy (WPRT).
* To determine if grade 2+ hematologic toxicity (CTCAE v. 4.0) is reduced with IMRT compared to conventional WPRT.
* To determine if urinary toxicity is reduced with IMRT using the EPIC urinary domain.
* To validate EPIC bowel and urinary domains in women undergoing either IMRT pelvic radiation treatment or four-field pelvic radiation treatment for endometrial or cervical cancer.
* To assess the impact of pelvic IMRT on quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) with cervix subscale.
* To determine if there is any difference in local-regional control, disease-free survival, and overall survival between patients treated with IMRT as compared to conventional WPRT.
* To perform a health-utilities analysis to measure the financial impact of pelvic IMRT via the EQ-5D instrument.
* To identify molecular predictors of radiation toxicity and novel circulating cancer biomarkers.
OUTLINE: This is a multicenter study. Patients are stratified according to type of cancer (endometrial vs cervical), chemotherapy (none vs 5 courses of weekly cisplatin at 40 mg/m²), and radiation dose (45 Gy vs 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo standard (3-dimensional) radiation therapy 5 days a week for up to 5-6 weeks.
* Arm II: Patients undergo intensity-modulated radiation therapy (IMRT) 5 days a week for up to 5-6 weeks.
Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression.
Tissue and blood samples may be collected for biomarker and correlative analysis.
Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite \[EPIC\], the Functional Assessment of Cancer Therapy-General \[FACT-G, Version 4\], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome \[PRO-CTCAE\]) instruments at baseline and periodically during and after study therapy.
After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 289
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Radiation Therapy intensity-modulated radiation therapy Standard radiation therapy (4-field) to the pelvis of either 45 Gy or 50.4 Gy Intensity-Modulated Radiation Therapy Standard radiation therapy intensity-modulated radiation therapy (IMRT) to the pelvis of either 45 Gy or 50.4 Gy
- Primary Outcome Measures
Name Time Method Acute Gastrointestinal Toxicity, as Measured by Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain Score at 5 Weeks From the Start of Pelvic Radiation Baseline and week 5 of RT The primary endpoint is change in acute GI toxicity, as measured by the EPIC bowel domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
- Secondary Outcome Measures
Name Time Method Urinary Toxicity, as Measured by Change in EPIC Urinary Domain Baseline, week 3 and 5 of RT, and 4-6 weeks after RT The primary endpoint is change in acute GI toxicity, as measured by the EPIC urinary domain, from baseline to 5 weeks after the first fraction of radiation is delivered. The EPIC has four domains (bowel, urinary, sexual, and hormonal) that have been validated separately, which allows use of only the domains of interest. The EPIC urinary domain consists of 12 items and has a function subscale (5 items) and bother subscale (7 items). For each domain, responses form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, where higher scores correspond to better quality of life. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Change was calculated as follow-up score - baseline score so a negative change score indicates a decline in function.
Overall Survival From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Identification of Molecular Predictors of Radiation Toxicity and Novel Circulating Cancer Biomarkers Outcome measure will not be analyzed Spearman's Correlation Coefficient for EPIC Bowel Domain vs. Urinary Domains (Validation - Conceptual Independence) Baseline and week 5 of RT The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Spearman's rank correlation coefficient is a nonparametric measure of rank correlation between two variables with a value between +1 and -1, where 1 is total positive rank correlation, 0 is no rank correlation, and -1 is total negative rank correlation.
Pearson Correlation Coefficient for EPIC Bowel and Urinary Domains vs. FACT-G Total Score (Validation - Criterion Validity) Baseline and week 5 of RT The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. The FACT-G is 27-item measure. Higher scores represent higher QOL. Each item has 5 responses options, 0=Not a lot and 4=Very much. Items are added together for the total score, ranging from 0-108. Certain items must be reversed before adding by subtracting the response from 4. The Pearson correlation coefficient is a measure of the linear correlation between two variables with a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.
Quality of Life, as Measured by Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) and FACT-Cx (Cervix) Subscale Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT The FACT-G is a validated, 27-item measure where a higher score represents higher QOL. In addition to a total QOL score, subscale scores for physical, functional, social and emotional well-being are produced. There are 5 responses options, with 0=Not a lot and 4=Very much. All items in a subscale are added together to obtain subscale totals. Scores range from 0-108 for the FACT-G total score, 0-28 for physical, social, functional, and 0-24 for emotional subscale. Certain items must be reversed before it is added by subtracting the response from 4. Subscale totals are summed to form the FACT-G total score. The FACT-Cx is 5-items, with score ranging 0-60, but is not included in total FACT-G. Each subscale requires \>= 50% of items completed and overall response rate must be greater than 80%. If items are missing, the subscale scores can be prorated. Change calculated as follow-up score - baseline score so that a negative change score indicates a decline in function.
Health Utilities, as Measured by Change From Baseline in EQ-5D Baseline, week 5 of RT, 4-6 weeks after RT The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm 10-point interval scale. Worst imaginable health state is scored as 0 at the bottom of the scale, and best imaginable health state is scored as 100 at the top. Both the 5-item index score and the VAS score are transformed into a utility score between 0 (worst health state) and 1 (best health state). Change from baseline is calculated as score at the timepoint of interested - baseline score.
Percentage of Patients With Acute Grade 2+ GI Toxicity at 5 Weeks From the Start of Treatment Baseline to Week 5 of RT Adverse events are graded using CTCAE v4.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
Disease-free Survival From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. Disease (progression) is defined as local recurrence, para-aortic recurrence, or distant metastasis. Local recurrence is defined as a disease in the radiation treatment field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Distant metastasis is defined as involvement of another organ or peritoneal disease. Disease-free survival time is defined as time from randomization to the date of progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Local-regional Recurrence From randomization to last follow-up. Maximum follow-up at time of analysis was 37.8 months. Local recurrence is defined as a disease in the radiation treatment field. This can include a local vaginal recurrence or nodal disease within the field. Para-aortic recurrence is defined as new lymphadenopathy in the para-aortic distribution. Local-regional control time is defined as time from randomization to the date of local recurrence, last known follow-up (censored), or death (competing risk). Local-regional recurrence rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Three-year rates are provided. Analysis occurred after all patients had been on study for at least 3 years.
Standardized Cronbach's Alpha for EPIC Bowel and Urinary Domains (Validation - Internal Consistency Reliability) Baseline and week 5 of RT The EPIC bowel domain consists of 14 items and has a function subscale (7 items) and bother subscale (7 items). The EPIC urinary domain consists of 12 total items and 4 subscales, functional (5 items), bother (7), incontinence (4) and irritative/obstructive (7). For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life. A domain score is the average of the transformed item scores. At least 80% of the items in a domain or subscale of the domain must be completed in order to compute the score. Cronbach's alpha is an internal consistency estimate of reliability of psychometric test scores and is a function of the number of items in a test, the average covariance between item-pairs, and the variance of the total score. An alpha of 0.60-0.79 was to be considered acceptable reliability; higher than 0.8 was to be considered good reliability.
Mean Change From Baseline in EPIC Bowel and Urinary Domain (Validation - Sensitivity to Treatment) Baseline and week 5 of RT The EPIC bowel domain and urinary domains consist of 14 and 12 items, respectively. For each item, responses form a Likert scale which are transformed to a 0-100 scale in which higher scores correspond to better quality of life (QOL). A domain score is the average of the transformed item scores. At least 80% of the items in a domain must be completed in order to compute the score. Difference is calculated as baseline - week 5.
A positive change score represents a decline in function.
Trial Locations
- Locations (137)
Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
The Mark H Zangmeister Center
🇺🇸Columbus, Ohio, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Virginia Mason CCOP
🇺🇸Seattle, Washington, United States
Arizona Oncology-Deer Valley Center
🇺🇸Phoenix, Arizona, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Arizona Oncology Services Foundation
🇺🇸Scottsdale, Arizona, United States
National University Hospital
🇸🇬Singapore, Singapore
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
Northside Hospital-Forsyth
🇺🇸Cumming, Georgia, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Christiana Care Health System-Christiana Hospital
🇺🇸Newark, Delaware, United States
Beebe Health Campus
🇺🇸Rehoboth Beach, Delaware, United States
Jackson Memorial Hospital-Holtz Children's Hospital
🇺🇸Miami, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Leeward Radiation Oncology Center
🇺🇸'Ewa Beach, Hawaii, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Saint Alphonsus Cancer Care Center-Boise
🇺🇸Boise, Idaho, United States
Radiation Oncology Associates PC
🇺🇸Fort Wayne, Indiana, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
Franciscan Saint Margaret Health-Dyer Campus
🇺🇸Dyer, Indiana, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Southwest General Health Center Ireland Cancer Center
🇺🇸Middleburg Heights, Ohio, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
Sanford USD Medical Center - Sioux Falls
🇺🇸Sioux Falls, South Dakota, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
UHHS-Chagrin Highlands Medical Center
🇺🇸Orange Village, Ohio, United States
Sanford Clinic North-Bemidgi
🇺🇸Bemidji, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Edwards Comprehensive Cancer Center
🇺🇸Huntington, West Virginia, United States
Dana-Farber/Brigham and Women's Cancer Center at South Shore
🇺🇸South Weymouth, Massachusetts, United States
Summa Barberton Hospital
🇺🇸Barberton, Ohio, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
🇺🇸Mount Holly, New Jersey, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Sanford Bismarck Medical Center
🇺🇸Bismarck, North Dakota, United States
North Shore-LIJ Health System/Center for Advanced Medicine
🇺🇸New Hyde Park, New York, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Paoli Memorial Hospital
🇺🇸Paoli, Pennsylvania, United States
Coastal Carolina Radiation Oncology
🇺🇸Wilmington, North Carolina, United States
Capital Health Medical Center-Hopewell
🇺🇸Pennington, New Jersey, United States
Geaugra Hospital
🇺🇸Chardon, Ohio, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Virtua West Jersey Hospital Voorhees
🇺🇸Voorhees, New Jersey, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Aurora BayCare Medical Center
🇺🇸Green Bay, Wisconsin, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
Logan Regional Hospital
🇺🇸Logan, Utah, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Summa Health Center at Lake Medina
🇺🇸Medina, Ohio, United States
South Atlantic Radiation Oncology
🇺🇸Supply, North Carolina, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
BCCA-Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
BCCA-Vancouver Island Cancer Centre
🇨🇦Victoria, British Columbia, Canada
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Pamela Youde Nethersole Eastern Hospital
🇭🇰Chai Wan, Hong Kong
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
Saint John's Mercy Medical Center
🇺🇸Saint Louis, Missouri, United States
Lake University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
UHHS-Westlake Medical Center
🇺🇸Westlake, Ohio, United States
Reading Hospital
🇺🇸West Reading, Pennsylvania, United States
Radiation Therapy Oncology Group
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Grady Health System
🇺🇸Atlanta, Georgia, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Emory University/Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Saint Joseph's-Candler Health System
🇺🇸Savannah, Georgia, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
McFarland Clinic PC-William R Bliss Cancer Center
🇺🇸Ames, Iowa, United States
Advocate Illinois Masonic Medical Center
🇺🇸Chicago, Illinois, United States
Ingalls Memorial Hospital
🇺🇸Harvey, Illinois, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
🇺🇸Anderson, Indiana, United States
Franciscan Saint Margaret Health-Hammond Campus
🇺🇸Hammond, Indiana, United States
D'Amour Center for Cancer Care
🇺🇸Springfield, Massachusetts, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
Penrose-Saint Francis Healthcare
🇺🇸Colorado Springs, Colorado, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Rocky Mountain Cancer Centers-Littleton
🇺🇸Littleton, Colorado, United States
Summa Akron City Hospital/Cooper Cancer Center
🇺🇸Akron, Ohio, United States
Dixie Medical Center Regional Cancer Center
🇺🇸Saint George, Utah, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
California Cancer Center - North Fresno
🇺🇸Fresno, California, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Kaiser Permanente Oakland-Broadway
🇺🇸Oakland, California, United States
Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
Saint Joseph Hospital - Orange
🇺🇸Orange, California, United States
Feather River Cancer Center
🇺🇸Paradise, California, United States
Rohnert Park Cancer Center
🇺🇸Rohnert Park, California, United States
The Permanente Medical Group-Roseville Radiation Oncology
🇺🇸Roseville, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center
🇺🇸Rancho Cordova, California, United States
Kaiser Permanente Medical Center - Santa Clara
🇺🇸Santa Clara, California, United States
Kaiser Permanente Cancer Treatment Center
🇺🇸South San Francisco, California, United States
Mercy Cancer Center-West Lakes
🇺🇸Clive, Iowa, United States
Peninsula Regional Medical Center
🇺🇸Salisbury, Maryland, United States
Lowell General Hospital
🇺🇸Lowell, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
🇺🇸Milford, Massachusetts, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Saint Francis Hospital
🇺🇸Federal Way, Washington, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
University of California at Davis Cancer Center
🇺🇸Sacramento, California, United States
South Sacramento Cancer Center
🇺🇸Sacramento, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Hawaii
🇺🇸Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
🇺🇸Honolulu, Hawaii, United States
Ochsner Medical Center Jefferson
🇺🇸New Orleans, Louisiana, United States
Wayne State University/Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States