Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

June 29, 2006

Last Updated Date

December 9, 2008

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Local control of cancer at two years post treatment
Response to preoperative chemoradiation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00347256 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Paranasal Sinus Neoplasms

Intervention ^ICMJE

Drug: cisplatin
Procedure: targeted radiation therapy
Procedure: tumor resection

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00347256

Responsible Party

Study ID Numbers ^ICMJE

NASBS-PNS001

Study Sponsor ^ICMJE

University of Tennessee

Collaborators ^ICMJE

North American Skull Base Society

Investigators ^ICMJE

Study Chair:	Sandeep Samant, MS, FRCS	University of Tennessee Health Science Center
Principal Investigator:	Sandeep Samant, MS, FRCS	University of Tennessee Health Science Center

Information Provided By

University of Tennessee

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP