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| Descriptive Information Fields | |||||||||
| Brief Title † | Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer | ||||||||
| Official Title † | 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 † | Interventional | ||||||||
| Study Design † | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Local control of cancer at two years post treatment Response to preoperative chemoradiation |
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| Secondary Outcome Measure † | Estimation of the proportion of the inoperable tumors which become operable after chemoradiation Identification of factors that are associated with inoperability Estimation of the overall survival and cumulative incidence of death due to disease at 2 years Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy. |
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| Condition † | Paranasal Sinus Neoplasms | ||||||||
| Intervention † | Drug: cisplatin Procedure: targeted radiation therapy Procedure: tumor resection |
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| MEDLINE PMIDs | |||||||||
| Links | North American Skull Base Society webpage  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Not yet recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Start Date † | |||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00347256 | ||||||||
| Organization ID | NASBS-PNS001 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | University of Tennessee | ||||||||
| Collaborators †† | North American Skull Base Society | ||||||||
| Investigators † |
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| Information Provided By | University of Tennessee | ||||||||
| Verification Date | June 2006 | ||||||||
| First Received Date † | June 29, 2006 | ||||||||
| Last Updated Date | June 29, 2006 | ||||||||
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