Viewing Study NCT00309920


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Study NCT ID: NCT00309920
Status: UNKNOWN
Last Update Posted: 2009-02-09
First Post: 2006-03-29
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1234}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'lastUpdateSubmitDate': '2009-02-06', 'studyFirstSubmitDate': '2006-03-29', 'studyFirstSubmitQcDate': '2006-03-29', 'lastUpdatePostDateStruct': {'date': '2009-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival at 6 months to 5 years after treatment'}], 'secondaryOutcomes': [{'measure': 'Overall survival at 6 months to 5 years after treatment'}, {'measure': 'Toxicity by NCI toxicity criteria at every course and periodically thereafter'}, {'measure': 'Anemia and cognitive function by Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) at every course'}, {'measure': 'Local relapses at 6 months to 5 years after treatment'}]}, 'conditionsModule': {'keywords': ['stage IIIA breast cancer', 'stage IIIC breast cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.\n\nPURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the disease-free survival rate in women with stage III breast cancer treated with adjuvant chemotherapy with vs without darbepoetin alfa.\n\nSecondary\n\n* Compare local recurrence and overall survival in patients receiving these regimens.\n* Compare toxicity of these regimens in these patients.\n* Compare quality of life and fatigue frequency in patients treated with these regimens.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according the chemotherapy regimen (CEF vs TAC). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive 1 of the following regimens:\n\n * Regimen CEF: Patients receive cyclophosphamide IV, epirubicin hydrochloride IV, and fluorouracil IV on day 1.\n * Regimen TAC: Patients receive docetaxel IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1.\n\nTreatment repeats every 3 weeks for 6 courses in the absence of disease progression and unacceptable toxicity.\n\n* Arm II: Patients receive 1 of the following regimens:\n\n * Regimen CEF: Patients receive regimen CEF as in arm I. Patients receive darbepoetin alfa if hemoglobin falls to ≤ 13.0 g/dL. Darbepoetin alfa is discontinued when hemoglobin rises to \\> 14.0 g/dL.\n * Regimen TAC: Patients receive TAC as in arm I and darbepoetin alfa as in arm II, regimen CEF.\n\nQuality of life is assessed at baseline, before each chemotherapy course, at the completion of study therapy, and at 6 and 12 months.\n\nAfter completion of study treatment, patients are followed periodically.\n\nPROJECTED ACCRUAL: A total of 1,234 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Stage III disease (pT1, N2-3, M0)\n * No metastatic disease by thoracic x-ray, full-body bone scan, and liver sonography\n* No inflammatory disease or Paget's disease\n* Disease completely resected (R0) and ≥ 10 axillary lymph nodes removed\n\n * Underwent surgery approximately 42 days ago\n * At least 9 positive lymph nodes\n * No prior sequential mastectomy\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Female\n* Menopausal status not specified\n* ECOG performance status 0-1\n* WBC ≥ 3,500/mm\\^3\n* Creatinine ≤ 1.4 mg/dL\n* Platelet count ≥ 100,000/mm\\^3\n* Bilirubin ≤ 2.0 mg/dL\n* No pre-existing symptomatic peripheral neuropathy\n* Not pregnant or nursing\n* No hypersensitivity to darbepoetin alfa, epoetin alfa, or any of their components\n* No other malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No participation in another clinical study\n* No prior therapies that would preclude study participation"}, 'identificationModule': {'nctId': 'NCT00309920', 'briefTitle': 'Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Adjuvant Therapy of Breast Cancer: Impact of Erythropoiesis Stimulating Factors on Event Free Survival High Risk Breast Cancer Treatment', 'orgStudyIdInfo': {'id': 'CDR0000458037'}, 'secondaryIdInfos': [{'id': 'WGSG-ARA-PLUS'}, {'id': 'AVENTIS-WGSG-ARA-PLUS'}, {'id': 'SANOFI-WGSF-ARA-PLUS'}, {'id': 'EU-205108'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'darbepoetin alfa', 'type': 'BIOLOGICAL'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG'}, {'name': 'epirubicin hydrochloride', 'type': 'DRUG'}, {'name': 'fluorouracil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-26603', 'city': 'Aurich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-41-94-1802'}], 'facility': 'Kreiskrankenhaus Aurich', 'geoPoint': {'lat': 53.46963, 'lon': 7.48239}}, {'zip': 'D-50126', 'city': 'Bergheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2271-87-0'}], 'facility': 'Maria-Hilf-Krankenhaus', 'geoPoint': {'lat': 50.95572, 'lon': 6.63986}}, {'zip': 'D-51465', 'city': 'Bergisch', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2202-122-497'}], 'facility': 'Evangelisches Krankenhaus - Bergisch Gladbach'}, {'zip': 'D-53113', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-228-543-2401'}], 'facility': 'Johanniter-Krankenhaus Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': 'D-53119', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-228-908-1900'}], 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': 'D-53123', 'city': 'Bonn-Duisdorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-228-644-546'}], 'facility': 'Praxis fuer Haematologie - Onkologie'}, {'zip': 'D-44575', 'city': 'Castrop-Rauxel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2305-294-250'}], 'facility': 'St. Rochus Hospital', 'geoPoint': {'lat': 51.55657, 'lon': 7.31155}}, {'zip': 'D-50677', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-221-931-8220'}], 'facility': 'Praxis Fuer Haematologie Internistische Onkologie', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'D-50924', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-221-478-4940'}], 'facility': 'Medizinische Universitaetsklinik I at the University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'D-50935', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-221-4677-0-521'}], 'facility': 'St. Elisabeth-Krankenhaus - Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': 'D-94469', 'city': 'Deggendorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-991-380-3172'}], 'facility': 'Klinikum Deggendorf', 'geoPoint': {'lat': 48.84085, 'lon': 12.96068}}, {'zip': 'D-47055', 'city': 'Duisburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-211-811-7550'}], 'facility': 'Onkologische Schwerpunktpraxis', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': 'D-40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-211-811-7550'}], 'facility': 'Universitaetsklinikum Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': 'D-45117', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-201-434-2548'}], 'facility': 'Alfried Krupp Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-45122', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-201-723-2578'}], 'facility': 'Universitaetsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-90766', 'city': 'Fürth', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-911-976-1474'}], 'facility': 'II Medizinische Klinik - Klinikum Fuerth', 'geoPoint': {'lat': 49.42335, 'lon': 7.23919}}, {'zip': 'D-45879', 'city': 'Gelsenkirchen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-209-160-1201'}], 'facility': 'Evangelische Kliniken Gelsenkirchen GmbH', 'geoPoint': {'lat': 51.50508, 'lon': 7.09654}}, {'zip': 'D-47574', 'city': 'Goch', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2823-891-105'}], 'facility': 'Wilhelm-Anton-Hospital gGmbH, Goch', 'geoPoint': {'lat': 51.67873, 'lon': 6.15895}}, {'zip': 'D-48268', 'city': 'Greven', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2571-502-203'}], 'facility': 'Maria-Josef-Hospital Greven GmbH', 'geoPoint': {'lat': 52.09364, 'lon': 7.59396}}, {'zip': 'D-58095', 'city': 'Hagen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2331-201-2622'}], 'facility': 'Allgemeines Krankenhaus Hagen', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': 'D-58135', 'city': 'Hagen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2331-476-3825'}], 'facility': 'Evangelisches Krankenhaus Hagen-Haspe GmbH', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': 'D-30171', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-511-289-3350'}], 'facility': 'Henriettenstiftung Krankenhaus', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-31134', 'city': 'Hildesheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-5121-590-20'}], 'facility': 'Praxisgemeinschaft fuer Gynaekologische Onkologie', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': 'D-66424', 'city': 'Homburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-6841-162-8101'}], 'facility': 'Universitaetsklinikum des Saarlandes', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': 'D-87600', 'city': 'Kaufbeuren', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-8341-421-001'}], 'facility': 'Klinikum Kaufbeuren Ostallgaeu', 'geoPoint': {'lat': 47.88238, 'lon': 10.62192}}, {'zip': 'D-56073', 'city': 'Koblenz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-261-496-3101'}], 'facility': 'Katholisches Klinikum Koblenz Marienhof', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'zip': 'D-96317', 'city': 'Kronach', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-9261-5977-10'}], 'facility': 'Frankenwald Klinik', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': 'D-96317', 'city': 'Kronach', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-9261-624-8161'}], 'facility': 'Internistische Onkologische Praxis - Kronach', 'geoPoint': {'lat': 50.23963, 'lon': 11.33308}}, {'zip': 'D-44892', 'city': 'Langendreer', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-234-299-3300'}], 'facility': 'Knappschaft Krankenhaus', 'geoPoint': {'lat': 51.46023, 'lon': 7.32584}}, {'zip': 'D-44534', 'city': 'Lünen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2306-772-701'}], 'facility': 'St. Marien Hospital - Luenen', 'geoPoint': {'lat': 51.61634, 'lon': 7.52872}}, {'zip': 'D-55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-6131-575-1400'}], 'facility': 'St. Vincenz und Elisabeth Hospital', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-87700', 'city': 'Memmingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-8331-702-257'}], 'facility': 'Klinikum Memmingen', 'geoPoint': {'lat': 47.98372, 'lon': 10.18527}}, {'zip': 'D-32423', 'city': 'Minden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-571-801-4101'}], 'facility': 'Klinikum Minden', 'geoPoint': {'lat': 52.28953, 'lon': 8.91455}}, {'zip': 'D-47441', 'city': 'Moers', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2841-200-2600'}], 'facility': 'Krankenhaus Bethanien', 'geoPoint': {'lat': 51.45342, 'lon': 6.6326}}, {'zip': 'D-56564', 'city': 'Neuwied', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2631-821-213'}], 'facility': 'Marienhaus Klinikum St. Elisabeth Neuwied', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}, {'zip': 'D-46004', 'city': 'Oberhausen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-208-881-00'}], 'facility': 'Evangelisches Krankenhaus Oberhausen', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': 'D-63065', 'city': 'Offenbach', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-69-812-626'}], 'facility': 'Internistische Gemeinschaftspraxis - Offenbach', 'geoPoint': {'lat': 50.10061, 'lon': 8.76647}}, {'zip': 'D-48431', 'city': 'Rheine', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-5971-914-142'}], 'facility': 'Praxis fuer Haematologie und Onkoligie', 'geoPoint': {'lat': 52.28509, 'lon': 7.44055}}, {'zip': 'D-18059', 'city': 'Rostock', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-381-4401-4590'}], 'facility': 'Klinikum Suedstadt Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'D-58239', 'city': 'Schwerte', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2304-109-234'}], 'facility': 'Marienkrankenhaus Schwerte gem. GmbH', 'geoPoint': {'lat': 51.44387, 'lon': 7.5675}}, {'zip': 'D-42653', 'city': 'Solingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-212-547-2371'}], 'facility': 'Staedtisches Klinikum Solingen', 'geoPoint': {'lat': 51.17343, 'lon': 7.0845}}, {'zip': 'D-53840', 'city': 'Troisdorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2241-975-422'}], 'facility': 'Praxis Fuer Internistische Haematologie / Onkologie', 'geoPoint': {'lat': 50.80901, 'lon': 7.14968}}, {'zip': 'D-59423', 'city': 'Unna', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2303-100-2842'}], 'facility': 'Katherinen-Hospital gGmbH', 'geoPoint': {'lat': 51.53795, 'lon': 7.68969}}, {'zip': 'D-46483', 'city': 'Wesel', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-281-104-1160'}], 'facility': 'Marien-Hospital Wesel gGmbH', 'geoPoint': {'lat': 51.6669, 'lon': 6.62037}}, {'zip': 'D-58452', 'city': 'Witten', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-2302-173-1328'}], 'facility': 'Marien-Hospital Witten', 'geoPoint': {'lat': 51.44362, 'lon': 7.35258}}, {'zip': 'D-42109', 'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-202-290-2152'}], 'facility': 'Bethesda Krankenhaus Wuppertal gGmbH', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}, {'zip': 'D-42275', 'city': 'Wuppertal', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '49-202-254-1150'}], 'facility': 'Haematologie / Onkologische Schwerpunktpraxis', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Ulrike Nitz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Heinrich-Heine University, Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}}}}