Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

Paused · Phase 2

Conditions studied: Recurrent Head and Neck Carcinoma

In brief

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

Key facts

Study ID

NCT03164460

Run by

M.D. Anderson Cancer Center

People needed

68

Starts

2017-05-22

Expected to finish

2027-05-31

Last updated by the study team

2026-08-10

Who can join

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

You may qualify if…

• Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
• Not eligible for surgery for recurrence or poor surgical candidate
• Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
• 1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
• Negative pregnancy test for women of child bearing potential

You may not qualify if…

• Patients who are pregnant or breast feeding
• Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to:
• a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device
• b) No myocardial infarction within 3 months of registration
• Widely metastatic disease (oligometastatic disease acceptable)

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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