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Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00347256
Recruitment Status : Withdrawn
First Posted : July 4, 2006
Last Update Posted : December 10, 2008
North American Skull Base Society
Information provided by:
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Paranasal Sinus Neoplasms Drug: cisplatin Procedure: targeted radiation therapy Procedure: tumor resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Local control of cancer at two years post treatment
  2. Response to preoperative chemoradiation

Secondary Outcome Measures :
  1. Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
  2. Identification of factors that are associated with inoperability
  3. Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
  4. Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
  5. Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347256

Sponsors and Collaborators
University of Tennessee
North American Skull Base Society
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Study Chair: Sandeep Samant, MS, FRCS University of Tennessee Health Science Center
Principal Investigator: Sandeep Samant, MS, FRCS University of Tennessee Health Science Center
Additional Information:
Layout table for additonal information Identifier: NCT00347256    
Other Study ID Numbers: NASBS-PNS001
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: December 10, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Paranasal Sinus Neoplasms
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nose Diseases
Respiratory Tract Diseases
Paranasal Sinus Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Antineoplastic Agents