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Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
North American Skull Base Society
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00347256
First received: June 29, 2006
Last updated: December 9, 2008
Last verified: December 2008
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
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: 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

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

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

Additional relevant MeSH terms:
Neoplasms
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
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013