Clinical Trials /

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

NCT02388932

Description:

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy (SBRT) in treating participants with head and neck cancer that has spread from where it started to nearby tissue or lymph nodes and is at high risk for continuing to spread because the participant cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a specialized radiation therapy that delivers radiation directly to the tumor in smaller doses over several days, which may kill more tumor cells and cause less damage to normal tissue.

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Oropharyngeal Squamous Cell Carcinoma
Recruiting Status:

Terminated

Phase:

N/A

Trial Eligibility

Document

Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer

Title

  • Brief Title: Stereotactic Body Radiation Therapy in Treating Patients With High Risk Locally Advanced Head and Neck Cancer
  • Official Title: Phase I Dose Escalation Study of Stereotactic Body Radiotherapy for p16 Negative Squamous Cell Carcinoma of the Head and Neck in High Risk Patients Who Are Ineligible/Refuse Standard of Care Therapy
  • Clinical Trial IDs

    NCT ID: NCT02388932

    ORG ID: CASE8314

    NCI ID: NCI-2014-02279

    Trial Conditions

    Recurrent Hypopharyngeal Squamous Cell Carcinoma

    Recurrent Laryngeal Squamous Cell Carcinoma

    Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma

    Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Recurrent Oral Cavity Squamous Cell Carcinoma

    Recurrent Oropharyngeal Squamous Cell Carcinoma

    Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Stage III Hypopharyngeal Squamous Cell Carcinoma

    Stage III Laryngeal Squamous Cell Carcinoma

    Stage III Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma

    Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Stage III Oral Cavity Squamous Cell Carcinoma

    Stage III Oropharyngeal Squamous Cell Carcinoma

    Stage IVA Hypopharyngeal Squamous Cell Carcinoma

    Stage IVA Laryngeal Squamous Cell Carcinoma

    Stage IVA Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Stage IVA Oral Cavity Squamous Cell Carcinoma

    Stage IVA Oropharyngeal Squamous Cell Carcinoma

    Stage IVB Hypopharyngeal Squamous Cell Carcinoma

    Stage IVB Laryngeal Squamous Cell Carcinoma

    Stage IVB Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Stage IVB Oral Cavity Squamous Cell Carcinoma

    Stage IVB Oropharyngeal Squamous Cell Carcinoma

    Stage IVC Hypopharyngeal Squamous Cell Carcinoma

    Stage IVC Laryngeal Squamous Cell Carcinoma

    Stage IVC Nasopharyngeal Keratinizing Squamous Cell Carcinoma

    Stage IVC Oral Cavity Squamous Cell Carcinoma

    Stage IVC Oropharyngeal Squamous Cell Carcinoma

    Trial Interventions

    Drug Synonyms Arms

    Trial Purpose

    This phase I trial studies the side effects and best dose of stereotactic body radiation
    therapy in treating patients with head and neck cancer that has spread from where it started
    to nearby tissue or lymph nodes and is at high risk for continuing to spread because the
    patient cannot undergo standard chemotherapy. Stereotactic body radiation therapy is a
    specialized radiation therapy that delivers radiation directly to the tumor in smaller doses
    over several days, which may kill more tumor cells and cause less damage to normal tissue.

    Detailed Description

    PRIMARY OBJECTIVES:

    I. To explore the maximum tolerated dose of head and neck stereotactic body radiation
    therapy (SBRT) in a high risk patient population ineligible for standard chemoradiotherapy.

    SECONDARY OBJECTIVES:

    I. Assess profiles of SBRT toxicity and examine patient (including co-morbidities), tumor
    and treatment related factors that are associated with SBRT related toxicity.

    II. Identify any dose volume parameters that are associated with SBRT related toxicity.

    III. Explore potential dose response relationships between higher SBRT dosing and
    radiographic response.

    IV. Assess impact of SBRT on patients' quality of life.

    OUTLINE: This is a dose-escalation study.

    Patients undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.

    After completion of study treatment, patients are followed up at 0.5, 3, 6, 9, and 12
    months.

    Trial Arms

    Name Type Description Interventions
    Treatment (SBRT) Experimental Patients undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days.

    Eligibility Criteria

    Inclusion Criteria:

    - The patient must have squamous cell carcinoma proven by histologic diagnosis; for
    cancers of the oropharynx, p16 staining by immunohistochemistry must be negative; for
    cancers of the larynx, hypopharynx, oral cavity, nasopharynx, paranasal sinuses, p16
    staining is not required

    - The patient must have clinical stage T1-4, N0-3, M0-1, stage II-IVC carcinoma as per
    the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual;
    patients with T1N0M0 will be ineligible; patients with metastatic disease with a
    limited metastatic burden are eligible if obtaining local control is determined by
    their treating oncologist to be an important therapeutic goal

    - The patient must have imaging documenting a primary tumor, or involved lymph node, >=
    2.5 cm in greatest dimension

    - PET/CT is required for all patients, unless contraindicated; this may be acquired
    prior to study entry or after enrollment prior to SBRT planning

    - The patient must have a history and physical documented within four weeks of
    registration and be deemed by a medical oncologist to be ineligible for standard
    continuous course chemoradiotherapy with cisplatin

    - Karnofsky performance status (PS) >= 40

    - Female patients cannot be of childbearing age, or if they are, must have a negative
    pregnancy test prior to enrollment and be willing to use contraceptives during
    treatment and continue for 6 additional months

    - Patients must have the ability to understand and the willingness to sign a written
    informed consent document

    Exclusion Criteria:

    - Patients with T1N0M0 stage I disease

    - Patients who are receiving any other investigational agents

    - Patients with non-squamous cell histology

    - Patients with life expectancy < 6 months

    - Patients who cannot lie flat for 20 minutes

    - Patients with prior history of head and neck radiotherapy (> 40 Gy) with significant
    areas of anticipated overlap

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Maximum tolerated dose of SBRT determined by the incidence of dose limiting toxicities (DLTs) graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Secondary Outcome Measures

    Overall survival

    Local progression free survival

    Response measured according to standard Response Evaluation Criteria in Solid Tumors

    Incidence of SBRT related morbidity, graded according to NCI CTCAE version 4.0

    Quality of life assessed by Functional Assessment of Cancer Therapy-Head and Neck questionnaire

    Trial Keywords