Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
NCT ID: NCT00057746
Last Updated: 2016-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
265 participants
INTERVENTIONAL
2003-02-28
2013-11-30
Brief Summary
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PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
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Detailed Description
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* Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
* Compare quality of life of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.
* Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity.
* Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.
Patients are followed every 6 months for 1 year and then annually for 3 years.
PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I
Prophylactic cranial irradiation, 2.5 Gy fx
Prophylactic cranial irradiation, 2.5 Gy fx
Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
Arm II
Prophylactic cranial irradiation, 2.0 Gy fx
Prophylactic cranial irradiation, 2.0 Gy fx
Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
Arm III
Prophylactic cranial irradiation, 1.5 Gy fx
Prophylactic cranial irradiation, 1.5 Gy fx
Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
Interventions
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Prophylactic cranial irradiation, 2.5 Gy fx
Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
Prophylactic cranial irradiation, 2.0 Gy fx
Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
Prophylactic cranial irradiation, 1.5 Gy fx
Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
* Limited stage (I-IIIB)
* Confined to 1 hemithorax
* No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
* Complete response after induction chemotherapy (with or without thoracic radiotherapy)
* Consolidative chest radiotherapy may be initiated before study
* No radiographic evidence of any of the following:
* Brain metastases
* Normal brain CT scan or MRI less than 1 month before study
* Ipsilateral lung metastases
* Malignant pleural effusion
* Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray
PATIENT CHARACTERISTICS:
Age
* Not specified
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10.0 g/dL\^
Hepatic
* Not specified
Renal
* Not specified
Pulmonary
* See Disease Characteristics
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Neurological function class 1 or 2
* No epilepsy requiring permanent oral medication
* No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 1 week since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
* Concurrent thoracic radiotherapy allowed
Surgery
* Not specified
Other
* No concurrent antitumor agents
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Aaron H. Wolfson, MD
Role: STUDY_CHAIR
University of Miami Sylvester Comprehensive Cancer Center
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
Scottsdale, Arizona, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Scottsdale, Arizona, United States
Highlands Oncology Group - Springdale
Springdale, Arkansas, United States
Auburn Radiation Oncology
Auburn, California, United States
Radiation Oncology Centers - Cameron Park
Cameron Park, California, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
Pomona, California, United States
Radiation Oncology Center - Roseville
Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
Solano Radiation Oncology Center
Vacaville, California, United States
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
Bay Medical
Panama City, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Northwest Community Hospital
Arlington Heights, Illinois, United States
Rush-Copley Cancer Care Center
Aurora, Illinois, United States
St. Joseph Medical Center
Bloomington, Illinois, United States
Graham Hospital
Canton, Illinois, United States
Memorial Hospital
Carthage, Illinois, United States
St. Anthony's Memorial Hospital
Effingham, Illinois, United States
Eureka Community Hospital
Eureka, Illinois, United States
Galesburg Clinic, PC
Galesburg, Illinois, United States
Galesburg Cottage Hospital
Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States
Mason District Hospital
Havana, Illinois, United States
Hopedale Medical Complex
Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States
Kewanee Hospital
Kewanee, Illinois, United States
La Grange Memorial Hospital
La Grange, Illinois, United States
McDonough District Hospital
Macomb, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
BroMenn Regional Medical Center
Normal, Illinois, United States
Community Cancer Center
Normal, Illinois, United States
Community Hospital of Ottawa
Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States
Proctor Hospital
Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Illinois Valley Community Hospital
Peru, Illinois, United States
Perry Memorial Hospital
Princeton, Illinois, United States
St. Margaret's Hospital
Spring Valley, Illinois, United States
Valley Cancer Center
Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
Indianapolis, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Southwest Medical Center
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Wesley Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Fall River, Massachusetts, United States
South Suburban Oncology Center
Quincy, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States
Mecosta County Medical Center
Big Rapids, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States
Metro Health Hospital
Grand Rapids, Michigan, United States
Holland Community Hospital
Holland, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Hackley Hospital
Muskegon, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Immanuel St. Joseph's
Mankato, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Radiation Oncology Associates - Reno
Reno, Nevada, United States
Ocean Medical Center at Meridian Health
Brick, New Jersey, United States
John F. Kennedy Medical Center
Edison, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
Sparta, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
Middletown, New York, United States
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States
Highland Hospital of Rochester
Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Wayne Radiation Oncology
Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
Kinston Medical Specialists
Kinston, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Huron Hospital Cancer Care Center
Cleveland, Ohio, United States
Euclid Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
St. Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
MedCentral - Mansfield Hospital
Mansfield, Ohio, United States
St. Luke's Hospital
Maumee, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
St. Charles Mercy Hospital
Oregon, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
Salem, Ohio, United States
Firelands Regional Medical Center
Sandusky, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States
South Pointe Hospital Cancer Care Center
Warrensville Heights, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Three Rivers Community Hospital
Grants Pass, Oregon, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States
Providence Cancer Center at PMCC
Medford, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Arlington Cancer Center - Arlington
Arlington, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, United States
St. Joseph Cancer Center
Bellingham, Washington, United States
Harrison Medical Center
Bremerton, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Group Health Central Hospital
Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, , Canada
Countries
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References
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Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.
Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.
Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.
Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26.
Other Identifiers
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CDR0000258668
Identifier Type: -
Identifier Source: secondary_id
RTOG-0212
Identifier Type: -
Identifier Source: org_study_id
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