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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00054795 |
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Date of registration:
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10/02/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
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Scientific title:
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Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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550 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00054795 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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France
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Germany
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Netherlands
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults (=18 years old) with radiologically proven parenchymal brain metastases from
histologically confirmed non-small cell lung cancer;
- KPS score of =70;
- Each patient must sign a study-specific Informed Consent form
Exclusion Criteria:
- Liver metastases;
- Extracranial metastases in two or more organs;
- Known leptomeningeal metastases or subarachnoid spread of tumor;
- Prior whole brain radiation;
- Plan to use radiosurgery or radiation boost after completion of WBRT;
- Planned chemotherapy during study treatment (prior and subsequent chemotherapy is
allowed);
- Prior total resection of a single brain metastasis;
- Laboratory values as follows:
LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³;
Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;
- Women who are pregnant or lactating
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain Neoplasms
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Carcinoma, Non-Small-Cell Lung
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Metastases, Neoplasm
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Intervention(s)
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Drug: Motexafin Gadolinium
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Secondary ID(s)
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PCYC-0211
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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