Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)
4 other identifiers
interventional
59
1 country
174
Brief Summary
This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays 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. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2013
Typical duration for phase_2
174 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedStudy Start
First participant enrolled
November 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2018
CompletedResults Posted
Study results publicly available
August 5, 2019
CompletedAugust 5, 2019
June 1, 2019
4.6 years
April 1, 2013
June 19, 2019
August 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline v1.1 as a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location. Progression-free survival time is measured from the date of randomization to the date of first progression, death, or last known follow-up (censored). No statistical testing was done due to early study termination.
From randomization to study termination. Maximum follow-up was 39.0 months
Secondary Outcomes (6)
Percentage of Patients With Complete or Partial Response
From randomization to study termination. Maximum follow-up was 39.0 months
Number of Patients With Grade 3-5 Adverse Events
From randomization to study termination. Maximum follow-up was 39.0 months
Overall Survival
From randomization to study termination. Maximum follow-up was 39.0 months
Local-regional Progression-free Survival
From randomization to study termination. Maximum follow-up was 39.0 months
Distant Progression-free Survival
From randomization to study termination. Maximum follow-up was 39.0 months
- +1 more secondary outcomes
Study Arms (4)
EGFR: Erlotinib
EXPERIMENTALInduction erlotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
EGFR: No Erlotinib
ACTIVE COMPARATORChemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
ALK: Crizotinib
EXPERIMENTALInduction crizotinib for 12 weeks followed by chemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy. Patients who have had no response (partial or complete) after 6 weeks of induction therapy start chemoradiation therapy immediately.
ALK: No Crizotinib
ACTIVE COMPARATORChemotherapy (either cisplatin/etoposide or paclitaxel/carboplatin) and radiation therapy.
Interventions
30 once-daily 2 Gy fractions over 6 weeks totaling 60 Gy of intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3D-CRT).
Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. For patients receiving either erlotinib or crizotinib, carboplatin will begin 2 weeks after erlotinib or crizotinib, as applicable. Consolidation: 4-6 weeks after completion of RT, AUC=6, IV, days 1 and 22.
50 mg/m2, IV (intravenous), on days 1 and 8 of two 4-week cycles concurrent with radiation therapy. For patients receiving either erlotinib or crizotinib, cisplatin will begin 2 weeks after the completion of erlotinib or crizotinib, as applicable.
250 mg, orally, twice daily for four 3-week cycles (12 weeks in total)
150 mg, orally, once daily for four 3-week cycles (12 weeks in total)
50 mg/m2, IV, on days 1 and 8 of two 4-week cycles concurrent with radiation therapy. For patients receiving either erlotinib or crizotinib, etoposide will begin 2 weeks after the completion of erlotinib or crizotinib, as applicable.
Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. For patients receiving either erlotinib or crizotinib, carboplatin will begin 2 weeks after erlotinib or crizotinib, as applicable. Consolidation: 4-6 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed, newly diagnosed non-squamous NSCLC
- Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N2 or N3 disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
- Patients with any tumor (T) with node (N)2 or N3 are eligible; patients with T3, N1-N3 disease are eligible if deemed unresectable; patients with T4, any N are eligible
- Patients must have measurable disease, i.e., lesions that can be accurately measured in at least 1 dimension (longest dimension in the plane of measurement is to be recorded) with a minimum size of 10 mm by computed tomography (CT) scan (CT scan slice thickness no greater than 5 mm)
- Patients with a pleural effusion, which is a transudate, cytologically negative and non-bloody, are eligible if the radiation oncologist feels the tumor can be encompassed within a reasonable field of radiotherapy
- If a pleural effusion can be seen on the chest CT but not on chest x-ray and is too small to tap, the patient will be eligible; patients who develop a new pleural effusion after thoracotomy or other invasive thoracic procedure will be eligible
- The institution's pre-enrollment biomarker screening at a Clinical Laboratory Improvement Amendments (CLIA) certified lab documents presence of known "sensitive" mutations in epidermal growth factor receptor tyrosine kinase (EGFR TK) domain (exon 19 deletion, L858) and/or EML4-anaplastic lymphoma kinase (ALK) fusion arrangement; either the primary tumor or the metastatic lymph node tissue may be used for testing of mutations
- The institution's pre-enrollment biomarker screening at a CLIA certified lab documents absence of T790M mutation in the EGFR TK domain
- Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination, including recording of pulse, blood pressure (BP), weight, and body surface area, within 45 days prior to registration
- Whole body fludeoxyglucose-positron emission tomography (FDG-PET)/CT (orbits to mid-thighs) within 30 days prior to registration; PET/CT must be negative for distant metastasis
- CT scan with contrast of the chest and upper abdomen to include liver and adrenals (unless medically contraindicated) within 30 days prior to registration
- Magnetic resonance imaging (MRI) of the brain with contrast (or CT scan with contrast, if MRI medically contraindicated) within 30 days prior to registration
- Zubrod performance status 0-1 within 14 days prior to registration
- Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3
- +7 more criteria
You may not qualify if:
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 730 days (2 years) (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Atelectasis of the entire lung
- Contralateral hilar node involvement
- Exudative, bloody, or cytologically malignant effusions
- Severe, active co-morbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- Prior allergic reaction to the study drug(s) involved in this protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- NRG Oncologycollaborator
Study Sites (174)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, 93301, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Mercy UC Davis Cancer Center
Merced, California, 95340, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Saint Helena Hospital
St. Helena, California, 94574, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
21st Century Oncology-Palatka
Palatka, Florida, 32177, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Integrated Community Oncology Network-Flager Cancer Center
Saint Augustine, Florida, 32086, United States
Robert and Carol Weissman Cancer Center at Martin Health
Stuart, Florida, 34994, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, 30501, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
AMITA Health Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
AMITA Health Cancer Institute and Outpatient Center
Hinsdale, Illinois, 60521, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, 61114, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, 46016, United States
Radiation Oncology Associates PC
Fort Wayne, Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Concord Hospital
Concord, New Hampshire, 03301, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Community Medical Center
Toms River, New Jersey, 08755, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Mount Sinai Union Square
New York, New York, 10003, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Weill Medical College of Cornell University
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Summa Barberton Hospital
Barberton, Ohio, 44203, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, 44035, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, 74136, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Salem Hospital
Salem, Oregon, 97301, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Covenant Medical Center-Lakeside
Lubbock, Texas, 79410, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, 53051, United States
Columbia Saint Mary's Hospital - Ozaukee
Mequon, Wisconsin, 53097, United States
Columbia Saint Mary's Water Tower Medical Commons
Milwaukee, Wisconsin, 53211, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
The Alyce and Elmore Kraemer Cancer Care Center
West Bend, Wisconsin, 53095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study stopped accrual early due to unmet targeted accrual goals with 59 subjects accrued out of 234 planned.
Results Point of Contact
- Title
- Wendy Seiferheld
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Ramaswamy Govindan
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 2, 2013
Study Start
November 4, 2013
Primary Completion
June 4, 2018
Study Completion
June 4, 2018
Last Updated
August 5, 2019
Results First Posted
August 5, 2019
Record last verified: 2019-06