Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

December 9, 2008 updated by: University of Tennessee

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

North American Skull Base Society

Investigators

  • Study Chair: Sandeep Samant, MS, FRCS, University of Tennessee
  • Principal Investigator: Sandeep Samant, MS, FRCS, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria

June 29, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 10, 2008

Last Update Submitted That Met QC Criteria

December 9, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NASBS-PNS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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