Clinical Trial: Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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.

Detailed Summary:
Sponsor: University of Tennessee

Current Primary Outcome:

  • Local control of cancer at two years post treatment
  • Response to preoperative chemoradiation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: June 29, 2006
Date Started:
Date Completion:
Last Updated: December 9, 2008
Last Verified: December 2008