Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Paranasal Sinus Neoplasms
Both
Paranasal Sinus Neoplasms
Trial Information
Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Local control of cancer at two years post treatment
Principal Investigator
Sandeep Samant, MS, FRCS
Investigator Role:
Study Chair
Investigator Affiliation:
University of Tennessee Health Science Center
Authority:
United States: Department of Health and Human Services
Study ID:
NASBS-PNS001
NCT ID:
NCT00347256
Start Date:
Completion Date:
Related Keywords:
- Paranasal Sinus Neoplasms
- Neoplasms
- Paranasal Sinus Neoplasms
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