A Study to Evaluate the Safety and Efficacy of Zoledronic Acid in the Prevention or Delaying of Bone Metastasis in Patients With Stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC)
NCT ID: NCT00172042
Last Updated: 2015-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
437 participants
INTERVENTIONAL
2005-03-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Zoledronic acid
Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
Zoledronic acid 4 mg
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Control
No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
Zoledronic acid 4 mg
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Interventions
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Zoledronic acid 4 mg
Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly Diagnosed, Stage IIIA and Stage IIIB excluding patients with pleural effusion
* Patients must have received primary treatment for their disease and had no progression
Exclusion Criteria
* Treatment with other bisphosphonates in past 12 months
* Presence of metastases
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Jette, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Beijing, , China
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Guangzhou, , China
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Shanghai, , China
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Clamart, , France
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Clémont, , France
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Berlin, , Germany
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Coburg, , Germany
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Cologne, , Germany
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Essen, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Leipzig, , Germany
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Ludwigsburg, , Germany
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Mannheim, , Germany
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München, , Germany
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Neumünster, , Germany
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Trier, , Germany
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Ulm, , Germany
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Athens, , Greece
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Patra - RIO, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Deszk, , Hungary
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Mátraháza, , Hungary
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Pécs, , Hungary
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Bergamo, , Italy
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Carpi, , Italy
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Catania, , Italy
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Como, , Italy
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Cosenza, , Italy
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Livorno, , Italy
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Novara, , Italy
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Orbassano, , Italy
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Padua, , Italy
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Reggio Calabria, , Italy
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Rome, , Italy
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Taormina, , Italy
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Eindhoven, , Netherlands
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Hoofddorp, , Netherlands
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Lodz, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Seoul, , South Korea
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Alicante, , Spain
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Donostia / San Sebastian, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Sabadell, , Spain
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Lin-Ko, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chaingmai, , Thailand
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Aberdeen, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Sutton, , United Kingdom
Countries
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References
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Scagliotti GV, Kosmidis P, de Marinis F, Schreurs AJM, Albert I, Engel-Riedel W, Schallier D, Barbera S, Kuo HP, Sallo V, Perez JR, Manegold C. Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study. Ann Oncol. 2012 Aug;23(8):2082-2087. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.
Other Identifiers
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CZOL446G2419
Identifier Type: -
Identifier Source: org_study_id
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