Reirradiation for Small Inoperable Head and Neck Tumors

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done
because no one knows if one study group is better, the same, or worse than the other group.

- If you are assigned to Group 1, you will receive SBRT.

- If you are assigned to Group 2, you will receive conventional radiation therapy.

If you are unable to receive your randomly assigned treatment because it is no longer in your
best interest, you will not be asked to complete any of the procedures or visits listed
below. Study staff will, however, collect information from your medical record about the
status of the disease until the study ends.

Radiation Therapy:

If you are in Group 1, you will receive SBRT every other day for a total of 5 treatments
(about 2 weeks).

If you are in Group 2, you will receive conventional radiation therapy 1 time each weekday
(Monday-Friday) for a total of up to 30-35 treatments (about 6-7 weeks).

Length of Study:

Your active participation in this study will be over after the follow-up visits.

Study Visits:

During radiation treatment (1st week of treatment if you are receiving SBRT, 3rd or 4th week
if you are receiving conventional radiation therapy) and after receiving radiation treatment,
you will complete the same questionnaires that you did at baseline.

At each standard of care visit during your treatment:

- You will complete the same questionnaires that you did at baseline.

- If the doctor thinks it is needed, you will have an MRI and either a CT or PET-CT scan
at the Center for Advanced Biomedical Imaging to help with radiation treatment planning.

Follow-Up Visits:

About 2-3 months after your last radiation treatment, then every 3 months for 1 year, and
then every 3-4 months after that for up to 2 years:

- You will complete the same questionnaires that you did at baseline.

- If the doctor thinks it is needed, you will have a CT and PET-CT scan to check the
status of the disease.

Additional Information:

- Researchers will collect information from your medical record before, during, and for up
to 5 years after radiation therapy for this study. This information will be related to
your personal medical history, diagnosis, and the treatment you received or are
scheduled to receive for head and neck cancer.

- The questionnaires may be completed in person, by phone, or on REDcap (a secure,
web-based program used to collect data for research studies).

- A member of the study staff may contact you by phone, mail, or email to remind you to
complete the questionnaires.

Inclusion Criteria:

1. 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

2. Not eligible for surgery for recurrence or poor surgical candidate

3. Gross disease apparent on imaging (magnetic resonance imaging (MRI) or computed
tomography (CT))

4. 1-3 sites of recurrence (<60 cc per site, total volume <100 cc)

5. Age >/= 18 years

6. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2

7. Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

1. Patients who are pregnant or breast feeding

2. 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

3. Widely metastatic disease (oligometastatic disease acceptable)

4. Patients with a pacemaker