Prospective Trial of Serial CT Imaging for Evaluation of Dosimetric/Volumetric Changes During IMRT for Head/Neck Cancer

The investigator's hypothesis is that those patients with bulky head and neck cancers who
undergo definitive radiation therapy with or without chemotherapy have changes in their dose
distribution that lead to significant changes in dose to tumor and/or normal tissue. It is
possible for these dosimetric changes could occur in either those patients who undergo
resection or not. In this study those patients who have undergone a resection will be
stratified separately for analysis, however, this study is not powered to detect a difference
between the two groups. The rational for stratification into an operated group of patients is
that these patients will also lose weight in treatment and will provide us a detection of the
magnitude of change in dose caused by weight loss independent of tumor shrinkage.

Inclusion Criteria:

- AJCC pathological stage I-IV cancers of the head and neck meeting the following
criteria:

- If gross total resection is performed it must be completed within 7 weeks of
registration

- Site of tumor origin in the nasopharynx, oral cavity, oropharynx, parotid, larynx, or
hypopharynx (excluding lip, or sinuses)

- Pretreatment evaluations required for eligibility include:

- History and physical examination within four weeks prior to study entry

- Dental evaluation with management according to the guidelines in Appendix IV
prior to start of radiation

- Serum pregnancy test, if applicable, within one week prior to study entry; urine
dipstick test on the first day of treatment

- Radiographic Studies: Pre-operative CT or MRI of the primary tumor and neck for
clinical staging is required

- Patients must be ≥ 18 years of age.

- Women of childbearing potential (WOCBP) must be willing to consent to using effective
contraception while on treatment.

- Pregnant women are ineligible as radiation therapy involves unforeseeable risks to the
embryo or fetus. WOCBP must have a negative serum or urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [hCG], or in
accordance with local regulations, whichever is more sensitive).

- Patients must sign a study-specific informed consent form prior to registration.

Exclusion Criteria:

- Histology positive for melanoma.

- Gross (visible or palpable) disease left after surgery.

- Less than gross total resection or patients requiring staged surgery.

- Prior head and neck radiotherapy.

- Women of childbearing potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period