Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00283478 |
Recruitment Status :
Completed
First Posted : January 30, 2006
Last Update Posted : October 31, 2007
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Sponsor:
Kentuckiana Cancer Institute
Information provided by:
Kentuckiana Cancer Institute
Tracking Information | ||||
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First Submitted Date ICMJE | January 26, 2006 | |||
First Posted Date ICMJE | January 30, 2006 | |||
Last Update Posted Date | October 31, 2007 | |||
Study Start Date ICMJE | May 2004 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
To determine if Iscar improves immune function and quality of life. | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Iscar for Second Line Treatment of Advanced Non-Small Cell Lung Cancer | |||
Official Title ICMJE | Randomized Pilot Study of Supplemental Iscar in Combination With Gemcitabine vs. Gemcitabine Alone as Second Line Treatment for Advanced Non-Small Cell Lung Cancer. | |||
Brief Summary | To determine if Iscar Quercus improves immune function and quality of life among patients with stage IV non-small cell lung cancer. | |||
Detailed Description | RAndomized pilot study of supplemental Iscar in combination with Gemcitabine vs. Gemcitabine alone as second line treatment for advanced non-small cell lung cancer. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
20 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | April 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00283478 | |||
Other Study ID Numbers ICMJE | 1056757 Mistletoe |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Kentuckiana Cancer Institute | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Kentuckiana Cancer Institute | |||
Verification Date | October 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |