The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar
This study is currently recruiting participants.
Verified March 2012 by Simcere Pharmaceutical Co., Ltd
Sponsor:
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Simcere Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier:
NCT01564329
First received: March 21, 2012
Last updated: March 23, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 21, 2012 | ||||||||
| Last Updated Date | March 23, 2012 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
the change of blood perfusion before/after the use of Endostar [ Time Frame: per 3 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01564329 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar | ||||||||
| Official Title ICMJE | The Use of CT Perfusion to Determine the Normalization Window Period in the Treatment of Advanced Primary Lung Adenocarcinoma With Endostar | ||||||||
| Brief Summary | To evaluate the change of blood perfusion before/after the use of Endostar, discuss the time sequence of Endostar TM in treating advanced lung adenocarcinoma in normalization window period. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Advanced Primary Lung Adenocarcinoma | ||||||||
| Intervention ICMJE | Drug: endostar
Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | July 2013 | ||||||||
| Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01564329 | ||||||||
| Other Study ID Numbers ICMJE | sim-endo-201201 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Simcere Pharmaceutical Co., Ltd | ||||||||
| Study Sponsor ICMJE | Simcere Pharmaceutical Co., Ltd | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Simcere Pharmaceutical Co., Ltd | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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