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| Tracking Information | |||||||||
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| First Received Date ICMJE | June 29, 2006 | ||||||||
| Last Updated Date | December 9, 2008 | ||||||||
| Start Date ICMJE | |||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00347256 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer | ||||||||
| Official Title ICMJE | Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma | ||||||||
| Brief Summary | The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Paranasal Sinus Neoplasms | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | |||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00347256 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | NASBS-PNS001 | ||||||||
| Study Sponsor ICMJE | University of Tennessee | ||||||||
| Collaborators ICMJE | North American Skull Base Society | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Tennessee | ||||||||
| Verification Date | December 2008 | ||||||||
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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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