Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Paranasal Sinus Neoplasms

Intervention / Treatment
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* Drug: cisplatin
* Procedure: targeted radiation therapy
* Procedure: tumor resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Procedure: targeted radiation therapy|nan|
|Procedure: tumor resection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control of cancer at two years post treatment |  |  | 
| Response to preoperative chemoradiation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |