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Sponsors and Collaborators: |
University of Tennessee North American Skull Base Society |
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Information provided by: | University of Tennessee |
ClinicalTrials.gov Identifier: | NCT00347256 |
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.
Condition | Intervention |
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Paranasal Sinus Neoplasms |
Drug: cisplatin Procedure: targeted radiation therapy Procedure: tumor resection |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma |
Estimated Enrollment: | 60 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Sandeep Samant, MS, FRCS | University of Tennessee Health Science Center |
Principal Investigator: | Sandeep Samant, MS, FRCS | University of Tennessee Health Science Center |
Study ID Numbers: | NASBS-PNS001 |
Study First Received: | June 29, 2006 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00347256 |
Health Authority: | United States: Department of Health and Human Services; United States: Food and Drug Administration |
Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Cisplatin Respiratory Tract Diseases Nose Neoplasms |
Paranasal Sinus Neoplasms Head and Neck Neoplasms Sinus cancer Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Paranasal Sinus Diseases Nose Diseases |