Stereotactic post-operative radiation for head and neck skin squamous cell cancer involving the parotid/neck

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II randomized trial comparing ultrahypofractionated stereotactic postoperative radiotherapy (five sessions) to conventional fractionated postoperative radiotherapy (20–30 sessions) for node‑positive cutaneous squamous cell carcinoma of the head and neck. Patients are randomized 1:2 and stratified by pathologic nodal stage and planned or prior immunotherapy, and those receiving stereotactic radiation will also be compared to historical controls for the primary endpoint. The primary outcome is tumor control within the irradiated field at two years, and secondary outcomes include regional recurrence, disease‑free and overall survival, rates of salvage treatment, toxicity by CTCAE, and quality of life. The trial measures clinical efficacy, safety, and patient‑reported outcomes to determine whether the shorter regimen maintains cancer control with acceptable side effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Verspeeten Family Cancer Centre
  London, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Palma
• Email: david.palma@lhsc.on.ca
• Phone: 519-685-8500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.