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Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Oral Complications of Radiation Therapy

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
adjuvant therapy
management of therapy complications
quality-of-life assessment
intensity-modulated radiation therapy
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Head and Neck Cancer focused on measuring long-term effects secondary to cancer therapy in adults, oral complications of radiation therapy, radiation toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III basal cell carcinoma of the lip, stage III squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV squamous cell carcinoma of the lip and oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, metastatic squamous neck cancer with occult primary, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, recurrent lymphoepithelioma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent basal cell carcinoma of the lip, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced head and neck cancer
  • Indication for radiotherapy or chemoradiotherapy as primary or postoperative therapy AND meets 1 of the following criteria:

    • More than 75% of bilateral parotid glands expected to receive ≥ 45 cGy of radiation using conventional treatment field design
    • Either or both central auditory apparatus predicted to receive > 45 cGy of radiation

PATIENT CHARACTERISTICS:

  • No comorbid medical condition that would preclude radiotherapy
  • No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)
    Comparison of salivary function of patients in current study to salivary function of historical controls

    Secondary Outcome Measures

    Auditory, swallow, and voice function at 6 months after completion of IMRT
    Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
    Toxicities as measured by NCI CTCAE v3.0
    Improvement in IMRT/tomotherapy field design

    Full Information

    First Posted
    December 21, 2006
    Last Updated
    October 15, 2015
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00415025
    Brief Title
    Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer
    Official Title
    Evaluation of Normal Tissue Toxicities in Head and Neck Cancer Patients Receiving Intensity Modulated Radiotherapy (IMRT)
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Tests that measure how much saliva is made, hearing, swallowing, voice function, and quality of life may improve the ability to plan treatment for patients with advanced head and neck cancer and may help doctors find better ways to treat the cancer. PURPOSE: This clinical trial is studying the side effects of high-dose intensity-modulated radiation therapy in treating patients with advanced head and neck cancer.
    Detailed Description
    OBJECTIVES: Primary Assess salivary function in patients with advanced head and neck cancer treated with intensity-modulated radiotherapy (IMRT) by measuring stimulated saliva production at 6 and 12 months after completion of therapy. Compare salivary function in these patients to salivary function in historical controls. Secondary Assess auditory, swallow, and voice function and quality of life of these patients before and after IMRT or chemoradiotherapy. Advance experience with IMRT/tomotherapy and improve field design for irradiating head and neck cancer in an effort to reduce radiation dose and minimize effects on surrounding normal tissue. OUTLINE: This is a prospective study. Patients undergo standard of care high-dose intensity-modulated radiotherapy (IMRT) to the head and neck. Patients undergo baseline and post-treatment testing of auditory, salivary, swallow, and voice function as well as quality of life evaluation. Patients are evaluated for radiation-induced toxicities at 1, 6, and 12 months after completion of IMRT. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer, Long-term Effects Secondary to Cancer Therapy in Adults, Oral Complications of Radiation Therapy, Radiation Toxicity
    Keywords
    long-term effects secondary to cancer therapy in adults, oral complications of radiation therapy, radiation toxicity, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, stage III lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage III basal cell carcinoma of the lip, stage III squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV squamous cell carcinoma of the lip and oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III verrucous carcinoma of the oral cavity, stage IV adenoid cystic carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, stage IV verrucous carcinoma of the oral cavity, metastatic squamous neck cancer with occult primary, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III salivary gland cancer, stage IV salivary gland cancer, recurrent salivary gland cancer, recurrent lymphoepithelioma of the nasopharynx, recurrent lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent verrucous carcinoma of the larynx, recurrent adenoid cystic carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent verrucous carcinoma of the oral cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent basal cell carcinoma of the lip, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent metastatic squamous neck cancer with occult primary, untreated metastatic squamous neck cancer with occult primary

    7. Study Design

    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    adjuvant therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    management of therapy complications
    Intervention Type
    Procedure
    Intervention Name(s)
    quality-of-life assessment
    Intervention Type
    Radiation
    Intervention Name(s)
    intensity-modulated radiation therapy
    Primary Outcome Measure Information:
    Title
    Stimulated saliva production at 6 months after completion of intensity-modulated radiotherapy (IMRT)
    Title
    Comparison of salivary function of patients in current study to salivary function of historical controls
    Secondary Outcome Measure Information:
    Title
    Auditory, swallow, and voice function at 6 months after completion of IMRT
    Title
    Quality of Life (QOL) as assessed at baseline and at 1, 6, and 12 months after completion of IMRT
    Title
    Toxicities as measured by NCI CTCAE v3.0
    Title
    Improvement in IMRT/tomotherapy field design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed advanced head and neck cancer Indication for radiotherapy or chemoradiotherapy as primary or postoperative therapy AND meets 1 of the following criteria: More than 75% of bilateral parotid glands expected to receive ≥ 45 cGy of radiation using conventional treatment field design Either or both central auditory apparatus predicted to receive > 45 cGy of radiation PATIENT CHARACTERISTICS: No comorbid medical condition that would preclude radiotherapy No serious concurrent psychosocial, familial, sociological, geographical, or other condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul M. Harari, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Side Effects of High-Dose Intensity-Modulated Radiation Therapy in Treating Patients With Advanced Head and Neck Cancer

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