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NCT02388932 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2019-01-24

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Maximum Tolerated Dose (MTD) of Head and Neck SBRT

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outcome · POSTED

Incidence of Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Overall Survival

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outcome · POSTED

Local Progression Free Survival

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outcome · POSTED

Response Measured According to Standard Response Evaluation Criteria in Solid Tumors

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outcome · POSTED

Incidence of SBRT Related Morbidity

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outcome · POSTED

Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * The participant 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 participant 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; participants with T1N0M0 will be ineligible; participants 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 participant must have imaging documenting a primary tumor, or involved lymph node, ≥ 2.5 cm in greatest dimension * PET/CT is required for all participants, unless contraindicated; this may be acquired prior to study entry or after enrollment prior to SBRT planning * The participant 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 participants 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 * Participants must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants with T1N0M0 stage I disease * Participants who are receiving any other investigational agents * Participants with non-squamous cell histology * Participants with life expectancy \< 6 months * Participants who cannot lie flat for 20 minutes * Participants with prior history of head and neck radiotherapy (\> 40 Gy) with significant areas of anticipated overlap
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants undergo Stereotactic Body Radiation Therapy in 5 fractions at least 40 hours apart over 10-18 days. Three dose levels: 40Gy and 45Gy all in 5 fractions. Each initial dose level will have 6 participants allocated to them. All participants are assessed at their 3 month post SBRT visit for Dose-Limiting Toxicities (DLTs). If ≤1 participant experiences a DLT, participants will be enrolled at the next dose level. If ≥3 participants experience a DLT, further accrual will be permanently halted and the study stopped. If 2 participants experience a DLT, then an additional 6 participants will be enrolled at the same dose level. In this setting, if ≤ 3/12 participants have a DLT, participants will be enrolled at the next dose level. If ≥ 4/12 participants have a DLT, further accrual will be permanently halted and the study stopped and 35 Gy will not be recommended as safe. The dosing strategy for the 2nd (45Gy) cohort will be identical to the first.
    intervention Names
    1. Radiation: Stereotactic Body Radiation Therapy
    2. Device: Positron Emission Tomography
    3. Device: Computed Tomography
    4. Other: Quality-of-Life Assessment
    label
    Treatment (SBRT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (SBRT)
    description
    Undergo SBRT
    name
    Stereotactic Body Radiation Therapy
    other Names
    1. SBRT
    type
    RADIATION
  2. arm Group Labels
    1. Treatment (SBRT)
    description
    Undergo PET/CT
    name
    Positron Emission Tomography
    other Names
    1. Medical Imaging, Positron Emission Tomography
    2. PET
    3. PET Scan
    4. Positron Emission Tomography Scan
    type
    DEVICE
  3. arm Group Labels
    1. Treatment (SBRT)
    description
    Undergo PET/CT
    name
    Computed Tomography
    other Names
    1. CAT
    2. CAT Scan
    3. CT
    type
    DEVICE
  4. arm Group Labels
    1. Treatment (SBRT)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Maximum tolerated dose of SBRT in this patient population determined by the dose escalation design with doses '40Gy' and '45Gy all in 5 fractions'.
    measure
    Maximum Tolerated Dose (MTD) of Head and Neck SBRT
    time Frame
    3 months
  2. description
    Number of patients with dose limiting toxicity events graded according to CTCAE Version 4.0
    measure
    Incidence of Dose Limiting Toxicities (DLTs)
    time Frame
    3 months from start of treatment
secondary Outcomes
  1. description
    Kaplan-Meier estimates will be used to plot overall survival - the number of patients alive at 12 months followup
    measure
    Overall Survival
    time Frame
    Up to 12 months
  2. description
    Kaplan-Meier estimates will be used to plot local progression free survival.
    measure
    Local Progression Free Survival
    time Frame
    Up to 12 months
  3. description
    Trend tests will be used to investigate the relationship between SBRT dose and response.
    measure
    Response Measured According to Standard Response Evaluation Criteria in Solid Tumors
    time Frame
    Up to 12 months
  4. description
    Number of patients who experiences SBRT-related morbidity according to NCI CTCAE v 4.0
    measure
    Incidence of SBRT Related Morbidity
    time Frame
    Up to 12 months
  5. description
    Repeated analysis of variance measures will be used to analyze the quality of life data.
    measure
    Quality of Life Assessed by Functional Assessment of Cancer Therapy-Head and Neck Questionnaire
    time Frame
    Up to 12 months
Full study description
brief Summary
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.
detailed Description
PRIMARY OBJECTIVES: I. To explore the maximum tolerated dose of head and neck stereotactic body radiation therapy (SBRT) in a high risk participant population ineligible for standard chemoradiotherapy. SECONDARY OBJECTIVES: I. Assess profiles of SBRT toxicity and examine participant (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 participants' quality of life. OUTLINE: This is a dose-escalation study. Participants undergo SBRT in 5 fractions at least 40 hours apart over 10-18 days. After completion of study treatment, participants are followed up at 0.5, 3, 6, 9, and 12 months.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice