Stereotactic post-operative radiation for head and neck skin squamous cell cancer involving the parotid/neck
Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
NA · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT07337161
This trial tests whether a short, five‑session stereotactic radiation course works as well and has fewer side effects than the usual 20–30 session radiation after surgery for head and neck skin squamous cell carcinoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT07337161 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with biopsy‑confirmed cutaneous squamous cell carcinoma of the head and neck who have undergone definitive surgical resection, have node‑positive disease (N1–N3), are candidates for curative‑intent adjuvant radiation, and have ECOG performance status 0–2 are the intended participants.
Not a fit: Patients with distant metastatic disease, poor performance status (ECOG >2), non‑cutaneous histologies, or who are not candidates for curative‑intent adjuvant radiation are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, patients could get equally effective cancer control with far fewer treatment visits and potentially less long‑term toxicity and better quality of life.
How similar studies have performed: Hypofractionated and stereotactic radiation techniques have shown promising results in small series and other head and neck settings, but randomized data specifically for postoperative intraparotid cutaneous SCC are limited, so this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
London, Ontario
- Verspeeten Family Cancer Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Palma
- Email: david.palma@lhsc.on.ca
- Phone: 519-685-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cutaneous, Head and Neck Cancer Squamous Cell Carcinoma, skin, head and neck, radiation, SBRT, SABR