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Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

NCT ID: NCT00347256

Last Updated: 2008-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Paranasal Sinus Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cisplatin

Intervention Type DRUG

targeted radiation therapy

Intervention Type PROCEDURE

tumor resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North American Skull Base Society

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role lead

Principal Investigators

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Sandeep Samant, MS, FRCS

Role: STUDY_CHAIR

University of Tennessee

Sandeep Samant, MS, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Countries

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United States

Related Links

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http://www.nasbs.org

North American Skull Base Society webpage

Other Identifiers

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NASBS-PNS001

Identifier Type: -

Identifier Source: org_study_id