Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

• Verspeeten Family Cancer Centre, London, Ontario, Canada

Who to contact

Palma · 519-685-8500 · david.palma@lhsc.on.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07337161.