Status:
WITHDRAWN
Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
North American Skull Base Society
Conditions:
Paranasal Sinus Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00347256
Last Update
December 10 2008
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