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Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

Primary Purpose

Paranasal Sinus Neoplasms

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cisplatin
targeted radiation therapy
tumor resection
Sponsored by
University of Tennessee
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paranasal Sinus Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    June 29, 2006
    Last Updated
    December 9, 2008
    Sponsor
    University of Tennessee
    Collaborators
    North American Skull Base Society
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00347256
    Brief Title
    Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
    Official Title
    Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Tennessee
    Collaborators
    North American Skull Base Society

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Paranasal Sinus Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cisplatin
    Intervention Type
    Procedure
    Intervention Name(s)
    targeted radiation therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    tumor resection
    Primary Outcome Measure Information:
    Title
    Local control of cancer at two years post treatment
    Title
    Response to preoperative chemoradiation
    Secondary Outcome Measure Information:
    Title
    Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
    Title
    Identification of factors that are associated with inoperability
    Title
    Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
    Title
    Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
    Title
    Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandeep Samant, MS, FRCS
    Organizational Affiliation
    University of Tennessee
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sandeep Samant, MS, FRCS
    Organizational Affiliation
    University of Tennessee
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.nasbs.org
    Description
    North American Skull Base Society webpage

    Learn more about this trial

    Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer

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