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NCT00891904 · REGISTRY CONDITION SEARCH

Radiation Therapy and Cetuximab in Treating Patients With Recurrent 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
2016-04-14

RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.

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

Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30

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outcome · POSTED

Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients

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outcome · POSTED

Local and Distant Control

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outcome · POSTED

Overall Survival

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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
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx * Medically or surgically inoperable disease or patient refuses surgery * Recurrent disease * Previously irradiated disease meeting the following criteria: * Prior radiotherapy completed \> 6 months from re-irradiation * Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields * Majority of the recurrent tumor volume (\> 50%) received prior radiotherapy dose of 30-75 Gy * No distant metastatic disease PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 60 days after completion of study treatment * No prior allergic reaction to study drugs PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior surgical resection of the recurrent primary tumor and/or regional lymphatics
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5
    intervention Names
    1. Biological: cetuximab
    2. Radiation: stereotactic body radiation therapy
    label
    Cetuximab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cetuximab
    description
    Given IV
    name
    cetuximab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Cetuximab
    description
    Undergoing Radiotherapy
    name
    stereotactic body radiation therapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Grade 4-5 Toxicity as Assessed by NCI CTCAE v.30
    time Frame
    Daily while on Treatment
secondary Outcomes
  1. measure
    Feasibility as Assessed According to Ability to Deliver the Entire Treatment Regimen to 80% of Patients
    time Frame
    2 years
  2. measure
    Local and Distant Control
    time Frame
    very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter.
  3. measure
    Overall Survival
    time Frame
    very 2 months for year one, every 3-4 months for year 2, every 6 months for years 3 and 4 and annually thereafter
Full study description
brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic body radiation therapy together with cetuximab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects of radiation therapy given together with cetuximab and to see how well it works in treating patients with recurrent head and neck cancer.
detailed Description
OBJECTIVES: Primary * To assess the toxicity of stereotactic body radiotherapy delivered concurrently with cetuximab in patients with recurrent squamous cell carcinoma of the head and neck. Secondary * To assess the feasibility of delivering this regimen in these patients. * To assess the impact of this regimen on local control, distant control, and overall survival of these patients. OUTLINE: Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-5. Patients undergo 1 fraction of stereotactic-body radiotherapy (RT) in week 2. At 4 weeks after RT completion, patients may receive additional cetuximab IV combined with a 28-day chemotherapy regimen, per investigator discretion. After completion of study treatment, patients are followed every 2 months for 1 year, every 3-4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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      query cond
      Hypopharyngeal Cancer
      query disease state id
      ds-hypopharyngeal-cancer
      source file
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    Preserved source evidence · Not medical advice