Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

University of Tennessee60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Paranasal Sinus Neoplasms

Interventions

cisplatinDRUG

targeted radiation therapyPROCEDURE

tumor resectionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Local control of cancer at two years post treatment

Response to preoperative chemoradiation

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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