CutaneousHead and Neck Cancer Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
SBRTStandard Radiation
SBRT: Patients will receive ultra-hypofractionated stereotactic radiation over 5 treatments delivered every other weekday or twice weekly as follows:
* 40 to 42.5 Gy in 5 fractions: any areas of gross residual disease, or gross PNI on imaging
* 32.5 to 35 Gy in 5 fractions: microscopic areas at risk including positive margin and/or ENE
* 30 Gy in 5 fractions: entire operative bed including areas of primary tumor and involved nodes and dissected cervical nodal levels
* 27.5 to 30 Gy 5 fractions: at risk undissected cervical nodal levels adjacent to pathologically involved nodal levels, based on the discretion of the treating oncologist
Standard Radiation: Patients will receive daily conventional fractionation radiation over 4 or 6-6.5 weeks based on the treating oncologist's discretion. The below dose levels are recommended in the following clinical scenarios but may be modified per institutional standards: 20-fraction regimen or 30 to 33-fraction regimen
Study summary
The purpose of this study is to compare the effectiveness and side effects of stereotactic radiotherapy (5 sessions) against conventional (standard) radiotherapy (20-30 sessions) for the treatment of skin cancer involving the head and neck after surgical resection.
Stereotactic radiotherapy works in the same way that conventional (standard) radiotherapy does to kill cancer cells by damaging their genetic material and stopping the cancer cells from making copies of themselves.
This study will help the study doctors find out if this different approach is the same, better, or worse than the standard of care for your cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years
* Patient able to provide informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient is a candidate for curative intent treatment
* Patient is able to comprehend English adequately to complete patient reported outcome questionnaires
* Biopsy-confirmed cutaneous SCC
* Definitive resection of a primary cutaneous tumor within the head and neck
* Tumor stage T1-T4 (AJCC 8th edition); or tumor stage unknown (T0/Tx) with a positive intraparotid, peri-parotid or cervical node that is assumed to be from a head and neck cutaneous SCC by the treating oncologist
* Nodal stage N1-N3 (AJCC 8th edition)
* At least 1 indication for adjuvant radiation, including:
* T3 or T4 tumor stage
* Lymphovascular invasion (LVI)
* Perineural invasion (PNI)
* Positive or close (≤ 3 mm) margin
* ≥ 1 positive intraparotid, peri-parotid or cervical lymph node
* Multiple local recurrences or multi-focal disease
* Neoadjuvant or adjuvant immunotherapy is allowed
Exclusion criteria
* Definite metastatic disease at diagnosis
* Pregnant or breastfeeding women
* Significant health conditions or contraindications to receiving surgery and radiation
* History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)
* Prior head and neck radiation involving the ipsilateral parotid or neck. However, prior radiation to the index skin cancer that has led to the parotid nodal disease being treated on this trial is allowed, as long as there is no overlap, or inconsequential overlap, in the judgement of the treating oncologist.
* Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)
* Previous invasive malignancy within 5 years, unless controlled with no evidence of disease
Primary outcome measure(s)
Tumor control — 2 years Tumor control within the irradiated field at 2 years following adjuvant radiation completion defined as absence of clinical, radiographic or biopsy-proven recurrence within the irradiated field
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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