Surgery With or Without Adjuvant Stereotactic Body Radiotherapy

The primary objective of this study is to compare the 1-year local control in patients with
operable, recurrent previously-irradiated squamous cell head-and-neck cancers with or without
adjuvant SBRT. The secondary objectives of this study are to determine the locoregional
progression-free survival (PFS) distant PFS, overall PFS (local + regional + distant), and
overall survival (OS), to evaluate the acute and late toxicities of adjuvant SBRT in the
re-irradiation setting following salvage surgery, to determine prognostic factors that may
predict the likelihood of local failure, regional failure, or OS in this cohort to guide
future management, to compare the impact of adjuvant SBRT versus a wait-and-see approach on
patient reported quality of life (PR-QoL), and to compare surgical versus SBRT-induced
immunological serum markers in relation to local control.

Inclusion Criteria:

- Pathologically proven recurrent or second-primary head-and-neck cancer receiving prior
radiotherapy with or without chemotherapy.

- Prior radiotherapy to a dose of ≥50Gy

- No evidence of distant metastases

- Macroscopic complete salvage surgery with curative intent (surgery was not performed
only for biopsy or palliation). Final pathology and imaging must indicate a R0 or R1
resection (no gross disease remaining).

- High-risk pathologic features must be present: compromised/positive surgical margins
(≤ 2mm) or extra-nodal extension (patient with other high-risk features gross
perinueral invasion, bone invasion, angiolyphatic invasion, or a constellation of
these factors may be eligible based on case-by-case basis at discretion of principal
investigator).

- Karnofsky Performance Status ≥60 (ECOG 0-2)

- Any number or type of prior chemotherapy is allowed (patient may receive concurrent or
adjuvant systemic therapy such as cetuximab at the discretion of the treating
oncologic team)

Exclusion Criteria:

- Evidence of distant metastases on any staging or imaging modality

- Women who are breast feeding, or have a positive pregnancy test (reproductive age
should use effective birth control during study if randomized to SBRT treatment arm)

- Any patient with gross residual disease following salvage surgery

- Any co-morbidity or condition of sufficient severity to limit full compliance with the
protocol per assessment by the principal investigator.