Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
Not Applicable
Withdrawn
- Conditions
- Paranasal Sinus Neoplasms
- Registration Number
- NCT00347256
- Lead Sponsor
- University of Tennessee
- 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 Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Local control of cancer at two years post treatment Response to preoperative chemoradiation
- Secondary Outcome Measures
Name Time Method 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.