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Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

This study is not yet open for participant recruitment.
Verified by University of Tennessee, June 2006

Sponsors and Collaborators: University of Tennessee
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

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Cisplatin   

U.S. FDA Resources

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

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:   60

  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

Contacts
Contact: Sandeep Samant     901-448-5885     ssamant@utmem.edu    
Contact: Priscilla Adler     901-516-2763     padler@utmem.edu    

Locations
United States, Tennessee
University of Tennessee Health Science Center     Not yet recruiting
      Memphis, Tennessee, United States, 38104
      Principal Investigator: Sandeep Samant, MS, FRCS            

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

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

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

Study placed in the following topic categories:
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cisplatin
Respiratory Tract Diseases
Nose Neoplasms
Paranasal Sinus Neoplasms
Head and Neck Neoplasms
Sinus cancer
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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