Surgery With or Without Adjuvant Stereotactic Body Radiotherapy

Local progression-free-survival (LPFS) is the number of months from the initiation of study treatment until (local) progression of disease or death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.

Toxicities are assess according to the National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4. Acute toxicities are those seen within 3 months of completion of Stereotactic Body Radiotherapy. Toxicity in patients is documented immediately prior to randomization and 8-12 weeks post-treatment. Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events.

Toxicities will be assessed according to the National Cancer Institute Common Toxicity Criteria Events Scale (CTCAE), v4. Late toxicities will be those seen after 3 months of completion of Stereotactic Body Radiotherapy. Adverse events are Grade 1 and 2 and Serious Adverse events are Grade 3 and 4 events.

LRPFS is defined as the time from the date of randomization to the date of local or regional recurrence, whichever occurs first, or the date of death from any cause. Subjects who are alive and have not progressed will be censored at their last follow-up date. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.

Distant progression-free-survival (DPFS) is the time from the date of randomization to the date of distant progression or the date of death from any cause. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.

Overall progression free survival is the total of the three survival time measurements; PFS = local + regional + distant. Progression is defined as the appearance of a new metastatic lesion or objective tumor progression. Clinically detected lesions will only be considered measurable when superficial (vis-à-vis skin modules and palpable lymph nodes). The lesion must be accurately measured in at least one dimension ≥ 10mm. Methods for measuring disease status include CT, PET/CT or MRI.

The overall survival time is the measurement of time between the date of randomization and death from any cause.

The University of Washington Quality of Life questionnaire (revised) is a self-administered 16 item inquiry given to patients with head and neck cancer. The first 12 items ask the patient to score domains (such as pain, appearance, swallowing) from 0 (worse) to 100 (best). The arithmetic mean is then computed, yielding one number between 0 and 100. The higher the number, the "better" the patient is considered to be faring. The item simply asks the patient to choose the top 3 issues which have been bothering the patient over the past 7 days. The issues include physical symptoms, emotions and appearance. The final 3 questions provide a global assessment by asking the patient to consider their overall well-being over the past 7 days and provide possible answers ranging from excellent to very poor. For trial analysis: Period=1: before surgery, Period=2: after surgery, but before SBRT for patients in the SBRT arm, Period=3: after SBRT.