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

Stopped early · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02388932

Run by

Case Comprehensive Cancer Center

People needed

3

Starts

2015-03-03

Expected to finish

2017-02-06

Last updated by the study team

2019-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States
• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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