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

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.

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

Interventions

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

DEVICE

Positron Emission Tomography

Undergo PET/CT

DEVICE

Computed Tomography

Undergo PET/CT

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Shlomo Koyfman · Case Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-03

Primary Completion

2017-02-06

Completion

2017-02-06

FDA Device

Yes

Countries

• United States

Study Locations