Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma

University of Tennessee0 sites60 target enrollmentJuly 4, 2006

ConditionsParanasal Sinus Neoplasms

Drugscisplatin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Paranasal Sinus Neoplasms
Sponsor: University of Tennessee
Enrollment: 60
Primary Endpoint: Local control of cancer at two years post treatment
Status: Withdrawn
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 4, 2006

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Tennessee

Eligibility Criteria

Inclusion Criteria

•Karnofsky Performance Score: \>= 60
•Creatinin clearance \>= 50 ml/min or serum creatinine =\<1.5 mg/dl
•Total bilirubin, AST, ALT =\< 1.5 X laboratory uln
•ANC \>= 2000/mm3, platelets \>= 100,000/mm3
•Serum calcium within normal range
•T3 or T4 state tumors of paranasal sinuses
•Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma

Exclusion Criteria

•History of other malignancy in the last 3 years
•Other serious comorbidity that may significantly reduce the survival in next 5 years
•Pregnant or lactating women
•History of radiation to the head and neck region
•Paranasal sinus tumor is recurrent after prior treatment
•Presence of cervical node metastasis
•Presence of distant metastasis
•Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion

Outcomes

Primary Outcomes

Local control of cancer at two years post treatment

Response to preoperative chemoradiation

Secondary Outcomes

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.