Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

This study has been withdrawn prior to recruitment.

First Received: June 29, 2006 Last Updated: December 9, 2008 History of Changes

Sponsor:	University of Tennessee
Collaborator:	North American Skull Base Society
Information provided by:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00347256

Purpose

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.

Condition	Intervention
Paranasal Sinus Neoplasms	Drug: cisplatin Procedure: targeted radiation therapy Procedure: tumor resection

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347256

Sponsors and Collaborators

University of Tennessee

North American Skull Base Society

Investigators

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

More Information

Additional Information:

North American Skull Base Society webpage This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	NASBS-PNS001
Study First Received:	June 29, 2006
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00347256 History of Changes
Health Authority:	United States: Department of Health and Human Services; United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Paranasal Sinus Neoplasms
Paranasal Sinus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nose Diseases

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Nose Neoplasms
Therapeutic Uses
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009