Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 3:51 AM
Study NCT ID:
NCT00083304
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2004-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C067396', 'term': 'efaproxiral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 368}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-08', 'studyFirstSubmitDate': '2004-05-18', 'studyFirstSubmitQcDate': '2004-05-18', 'lastUpdatePostDateStruct': {'date': '2013-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Measured from randomization until death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Response Rate in the Brain at 3 Months', 'timeFrame': 'Assessed at screening, 3 months after end of study treatment and at least 4 weeks after the 3-month scan.'}, {'measure': 'Karnofsky Performance Status & Neurological Signs & Symptoms', 'timeFrame': 'Assessed at baseline, 1 month follow-up (FU) visit, 3 month FU visit, and 6 month FU visit.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast', 'Brain', 'RSR13', 'efaproxiral', 'Whole Brain Radiation Therapy', 'Brain metastases', 'Metastatic breast cancer'], 'conditions': ['Breast Cancer', 'Metastases']}, 'descriptionModule': {'briefSummary': 'RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.\n\nRSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.\n\nThis study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.', 'detailedDescription': 'The screening process will include documentation of the cancer, which which will require a brain scan and may include a liver scan. Other screening measurements will include a Karnofsky Performance Status (KPS) assessment, measurement of the amount of oxygen in the blood, using a non-invasive device most often placed on the finger, lung function tests that will require blowing into a machine, and an electrocardiogram (ECG). About 2 teaspoons, or 10 mL, of blood will be taken for specific laboratory tests, and a pregnancy test will be done on the blood of women of childbearing potential.\n\nAll study patients will receive supplemental oxygen and whole brain radiation therapy (WBRT) (30 Gy, 3 Gy fractions) every weekday for 2 weeks. Half of the patients will be randomized (assigned) to receive RSR13 prior to WBRT, and will need to have a central catheter placed for treatment unless one is already in place. Patients who receive RSR13 will also need to continue to receive oxygen in the clinic until the amount of oxygen in their blood is near normal. This level has returned to near normal in most patients within 1 to 2 hours.\n\nDuring treatment and follow-up visits, physical and neurological exam, KPS assessment, weight, height, and vital sign measurements, and about 2 teaspoons of blood may be required. Patients will need to return for follow-up visits 1 month after completion of treatment, 2 months later, and every 3 months thereafter until their doctor tells them otherwise.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women with brain metastases from breast cancer\n* Minimum KPS of 70\n\nExclusion Criteria:\n\n* Previous treatment for brain metastases, including brain surgery and any form of radiation to the brain'}, 'identificationModule': {'nctId': 'NCT00083304', 'acronym': 'ENRICH', 'briefTitle': 'Whole Brain Radiation Therapy With Oxygen, With or Without RSR13, in Women With Brain Metastases From Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spectrum Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer', 'orgStudyIdInfo': {'id': 'RT-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Efaproxiral + WBRT + Supplemental Oxygen', 'interventionNames': ['Drug: Efaproxiral', 'Radiation: Whole Brain Radiation Therapy (WBRT)', 'Other: Supplemental Oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WBRT + Supplemental Oxygen', 'interventionNames': ['Radiation: Whole Brain Radiation Therapy (WBRT)', 'Other: Supplemental Oxygen']}], 'interventions': [{'name': 'Efaproxiral', 'type': 'DRUG', 'otherNames': ['RSR13'], 'description': '75 mg/kg, administered over 30 minutes via a central venous access device (CVAD).\n\nAdministered 30 minutes prior to the start of whole brain radiation therapy (WBRT) on each WBRT treatment day for 10 days.', 'armGroupLabels': ['Efaproxiral + WBRT + Supplemental Oxygen']}, {'name': 'Whole Brain Radiation Therapy (WBRT)', 'type': 'RADIATION', 'description': '3.0 Gy per day for 10 days (30.0 Gy total) of WBRT.', 'armGroupLabels': ['Efaproxiral + WBRT + Supplemental Oxygen', 'WBRT + Supplemental Oxygen']}, {'name': 'Supplemental Oxygen', 'type': 'OTHER', 'description': '4 L/minute by nasal cannula.\n\nAdministered at least 35 minutes prior to WBRT, during WBRT and until 15 minutes after completion of WBRT on all WBRT treatment days.', 'armGroupLabels': ['Efaproxiral + WBRT + Supplemental Oxygen', 'WBRT + Supplemental Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Virginia G. Piper Cancer Center, Arizona Oncology Services', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724-5081', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center, University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'The University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Radiological Associates of Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Community Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Medical', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida - H. Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46805', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Parkview Research Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46204', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School of Medicine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Regional Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Oncology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21236', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Hematology Oncology', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Franklin Square Hospital Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Center for Cancer and Blood Disorders', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurologic Institute', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Downstate Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10469', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Eastchester Center for Cancer Care', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Breast Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Division of Hematology-Oncology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98801', 'city': 'Wenatchee', 'state': 'Washington', 'country': 'United States', 'facility': 'Wenatchee Valley Clinic', 'geoPoint': {'lat': 47.42346, 'lon': -120.31035}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'C1426ANZ', 'city': 'Buenos Aires', 'state': 'Cuidad de Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Medico Especializado Alexander Fleming', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'CP 1417', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto de Oncologia A. Roffo', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'CP C1209', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Espanol', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'CP 5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Instituto Privado de Radioterapia y Oncologia', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2000', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Centro de Terapia Radiante Cumbres (CAICI)', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'LKH-Universitatsklinikum Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '60430-230', 'city': 'Teófilo', 'state': 'Fortaleza Ceara', 'country': 'Brazil', 'facility': 'Hospital Sao Lucas PUC', 'geoPoint': {'lat': -19.33333, 'lon': -48.28333}}, {'zip': '14780-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Pio XII - Hospital do Câncer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '81520-060', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Hospital Erasto Gaertner', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Velindre Hospital', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': 'CEP 90020-090', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Hospital Santa Rita da Irmandade da Santa Casa', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': 'CEP 03102-002', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Brasileiro de Controle do Cancer', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Center', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Maisonneuve-Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM - Campus Notre Dame', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 5C3', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hotel-Dieu de Quebec du CHUQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitarie de Service de Radio-Oncologie', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Providencia', 'state': 'Santiago de Chile', 'country': 'Chile', 'facility': 'Cilnica Santa Maria', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'zip': '4', 'city': 'Osijek', 'country': 'Croatia', 'facility': 'Clinical Hospital Osijek', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'CHU Zagreb University School of Medicine', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '197', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital for Tumors', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges François Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '25209', 'city': 'Montbéliard', 'country': 'France', 'facility': 'Hopital de Montbeliard', 'geoPoint': {'lat': 47.50957, 'lon': 6.79823}}, {'zip': '06 189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antioned Lacasagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '22015', 'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'Clinique Armoricaine de', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Centre Rene Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '94 805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '151 23', 'city': 'Athens', 'country': 'Greece', 'facility': 'Hygeia Diagnostic and Therapeutic Center of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'country': 'Hungary', 'facility': 'University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': 'H-6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'University of Szeged', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Maggiore della Carita', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '56100', 'city': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale S Chiara, University of Pisa', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Kaunas Medical University Hospital', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-086660', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Institute of Oncology, Vilnius University', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '11', 'city': 'Lima', 'country': 'Peru', 'facility': 'Hospital Edgardo Rebagliati Martins (ESSALUD)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '27', 'city': 'Lima', 'country': 'Peru', 'facility': 'Radiooncologia, Radiation Oncology Center', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '34', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto de Enfermedades Neoplasicas (INEN)', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Catalan de Oncologia (ICO)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Ciutat Sanitari de Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon Y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universitaria de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncologia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'CF14 2TL', 'city': 'Whitchurch', 'state': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Velindre Hospital', 'geoPoint': {'lat': 52.96667, 'lon': -2.68333}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Royal Sussex County Hospital', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson Oncolgy Center', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'John Suh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spectrum Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Monitor', 'oldOrganization': 'Allos Therapeutics, Inc.'}}}}