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Clinical Trials/NCT00347256
NCT00347256WithdrawnNot Applicable

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

University of Tennessee0 sites60 target enrollmentStarted: July 4, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
60
Primary Endpoint
Local control of cancer at two years post treatment
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

Local control of cancer at two years post treatment

Response to preoperative chemoradiation

Secondary Outcomes

  • 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.

Investigators

Sponsor Class
Other

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