Imatinib Mesylate With or Without Bevacizumab in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
NCT ID: NCT00324987
Last Updated: 2017-09-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
12 participants
INTERVENTIONAL
2008-04-30
2015-07-31
Brief Summary
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Detailed Description
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I. To determine whether treatment with imatinib (imatinib mesylate) plus bevacizumab leads to improved progression free survival (PFS) versus treatment with imatinib alone in first-line treatment of incurable gastrointestinal stromal tumor (GIST).
SECONDARY OBJECTIVES:
I. To compare response probabilities (confirmed and unconfirmed complete response \[CR\] and partial response \[PR\] for subset of patients with measurable disease), overall survival, and central-review based progression-free survival (CRb-PFS) in patients treated with imatinib and bevacizumab versus those treated with imatinib alone.
II. To compare the frequency and severity of toxicities associated with imatinib plus bevacizumab versus imatinib alone.
TERTIARY OBJECTIVES:
I. To explore the association between soluble vascular endothelial growth factor (VEGF), VEGF-factor D (VEGF-D), VEGF receptor (VEGFR)-1, VEGFR-2, angiopoietin-2 (Ang-2), platelet-derived growth factor receptor (PDGFR)-AA and PDGFR-BB levels, positron emission tomography (PET) imaging and immunohistochemistry for cyclin-dependent kinase inhibitor 2A (p16), VEGF and VEGFR, with kinase mutation status and clinical outcomes.
II. To explore imatinib pharmacokinetics with single nucleotide polymorphisms involving the adenosine triphosphate (ATP)-binding cassette, sub-family G (WHITE), member 2 (ABCG2) and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) genes, as well as other genes that are reported to influence the absorption, distribution, metabolism and elimination of imatinib.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (CLOSED TO ACCRUAL 10/1/2009): Patients receive imatinib mesylate orally (PO) once daily (QD) on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1.
ARM II (CLOSED TO ACCRUAL 10/1/2009): Patients receive imatinib mesylate PO QD on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 6 months for 2 years, and then annually for 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 (CLOSED TO ACCRUAL 10/1/2009) (imatinib and bevacizumab)
Patients receive imatinib mesylate PO QD on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Bevacizumab
Given IV
Imatinib Mesylate
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Arm II (CLOSED TO ACCRUAL 10/1/2009) (imatinib)
Patients receive imatinib mesylate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Imatinib Mesylate
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Interventions
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Bevacizumab
Given IV
Imatinib Mesylate
Given PO
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) that is distantly metastatic or unresectable; patients must be determined to be unresectable for cure
* Patient may have measurable and/or non-measurable disease; computed tomography (CT) or magnetic resonance imaging (MRI) used for measurable disease must have been completed within 28 days prior to registration; CT or MRI used for non-measurable disease must have been completed within 42 days prior to registration; PET scans are not sufficient for disease assessment; all disease must be assessed and documented on the Baseline Tumor Assessment Form
* CT/MRI scans must be performed and submitted for central review; archived tissue must be submitted as outlined
* Institutions must seek additional patient consent for PET scans as outlined; if patient consents to the submission of PET scans, the patient must also be registered to Registration #2
* Patient must not have known brain metastasis
* Patient must have a Zubrod performance status of 0 - 3
* Patient must have resolution of transient toxicities from any prior chemotherapy, radiation therapy or surgery to =\< grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0)
* Patient may have previously received traditional chemotherapeutic agents in any setting, provided at least 28 days have elapsed since completing chemotherapy and they have recovered to =\< grade 1 from all drug-induced toxicities
* Patient must not have received prior treatment with bevacizumab or other agents targeting VEGF, VEGFR, or PDGFR for advanced disease; those agents may have been used in the adjuvant setting if the patient did not recur for at least 12 months following the completion of treatment; patients may be receiving imatinib for advanced disease prior to registration provided they meet ALL of the following criteria:
* Patient must not have received more than 30 days of imatinib treatment prior to registration
* Patients have not been restaged; (baseline disease assessments prior to initiation of imatinib must fulfill requirements)
* Patients must have no clinical signs of progression
* Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment and there is evidence of progressive disease within the radiation field or disease outside the radiation field
* Patient must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration, or anticipation of need for major surgical procedure during the course of the study; no fine needle aspirations or core biopsies are allowed within 7 days prior to registration; no procedure to place a port-a-cath is allowed within 7 days prior to registration
* Patient must have a total bilirubin =\< 2.0 x institutional upper limit of normal (IULN), obtained within 28 days prior to registration
* Patients without liver involvement must have serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2.5 x IULN, obtained within 28 days prior to registration; patients with liver involvement must have SGOT or SGPT =\< 5 x IULN
* Patient must have adequate renal function as defined by a serum creatinine =\< 1.5 x IULN obtained within 28 days prior to registration
* Patient must have urine protein/creatinine ratio (UPC) \< 1; this result must be obtained within 28 days prior to registration
* Patient must have an absolute neutrophil count (ANC) \>= 1,000/mcl obtained within 28 days prior to registration
* Patient must have a platelet count \>= 100,000/mcl obtained within 28 days prior to registration
* Patient must have hemoglobin \>= 9 gm/dl (this may be achieved by transfusion if needed) obtained within 28 days prior to registration
* Patient must have an international normalized ratio (INR) =\< 1.5, obtained within 28 days prior to registration
* Patient must have a partial thromboplastin time (PTT) =\< IULN, obtained within 28 days prior to registration
* Patient must not be taking therapeutic doses of Coumadin (warfarin) as anticoagulation at the time of registration; patients requiring therapeutic anticoagulation may use low-molecular weight heparin (e.g., Lovenox) or other agents, and mini-dose Coumadin (1 mg PO QD) as prophylaxis is allowed
* Patient must not have had a cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction or unstable angina within 6 months prior to registration; patient must not have serious cardiac arrhythmia requiring medication, New York Heart Association (NYHA) class II or greater congestive heart failure, or clinically significant peripheral vascular disease
* Patient must not have had an abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to registration
* Patient must not plan to use other investigational agents while on protocol treatment
* Patient must have no contraindication to oral medications (e.g., severe dysphagia); patients with gastrostomy (G)- or jejunostomy (J)- tubes are eligible
* Patient must not have blood pressure \> 160/90; patients with a history of hypertension must be on a stable regimen of anti-hypertensive therapy
* Patient must not have a serious, non-healing wound, ulcer, or bone fracture
* Patient must not be pregnant or nursing; male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout protocol treatment and for up to 6 months following discontinuation of study drugs
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
* If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
* At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
* REGISTRATION #2 - PET SUBSTUDY:
* Patient must have been registered to the main study
* Patient must have consented to the submission of PET scans
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Charles Blanke
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills - Peninsula Hospitals
Burlingame, California, United States
Marin General Hospital
Greenbrae, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Memorial University Medical Center
Savannah, Georgia, United States
South Georgia Medical Center
Valdosta, Georgia, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Presence Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States
Edward Hospital/Cancer Center
Naperville, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Carle Clinic-Urbana Main
Urbana, Illinois, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Genesis Medical Center - West Campus
Davenport, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, United States
Providence Hospital-Southfield Cancer Center
Southfield, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States
Miller-Dwan Hospital
Duluth, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Woodwinds Health Campus
Woodbury, Minnesota, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Highland Hospital
Rochester, New York, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Health Center
Dayton, Ohio, United States
Dayton CCOP
Dayton, Ohio, United States
Veteran Affairs Medical Center
Dayton, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Saint Luke's Hospital
Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Adventist Medical Center
Portland, Oregon, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Geisinger South Wilkes-Barre
Wilkes-Barre, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Audie L Murphy Veterans Affairs Hospital
San Antonio, Texas, United States
University Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
West Virginia University Charleston
Charleston, West Virginia, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, United States
Diagnostic and Treatment Center
Weston, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Tom Baker Cancer Centre
Calgary, Alberta, Canada
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Countries
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References
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Blanke CD, Rankin C, Corless C, Eary JF, Mulder K, Okuno SH, George S, Heinrich M. S0502: A SWOG Phase III Randomized Study of Imatinib, With or Without Bevacizumab, in Patients With Untreated Metastatic or Unresectable Gastrointestinal Stromal Tumors. Oncologist. 2015 Dec;20(12):1353-4. doi: 10.1634/theoncologist.2015-0295. Epub 2015 Nov 17.
Other Identifiers
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NCI-2009-00776
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000482236
Identifier Type: -
Identifier Source: secondary_id
S0502
Identifier Type: OTHER
Identifier Source: secondary_id
S0502
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00776
Identifier Type: -
Identifier Source: org_study_id
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