Paranasal Sinus Neoplasms
Conditions
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.
Interventions
Sponsors
North American Skull Base Society
University of Tennessee
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control of cancer at two years post treatment | — |
| Response to preoperative chemoradiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Estimation of the overall survival and cumulative incidence of death due to disease at 2 years | — |
| Estimation of the proportion of the inoperable tumors which become operable after chemoradiation | — |
| Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy. | — |
| Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen | — |
| Identification of factors that are associated with inoperability | — |
Outcome results
None listed