💬In plain words
What the trial is, and whether it could suit you
The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery.
The main questions it aims to answer are:
Does short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation?
Researchers will compare:
Short-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness.
Active surveillance for moderate-risk patients to expected recurrence rates to assess safety.
Participants will:
High-Risk Group (SCRT): Receive short-cour
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Pathologically confirmed cutaneous squamous cell carcinoma of the head \& neck region, defined as extending from vertex of head to supraclavicular region.
* Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration
* Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup:
* Clinical exam within 60 days prior to registration
* CT head \& neck/soft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.
* Bilateral neck ultrasound within 60 days prior to registration
* Risk Factors fitting either the High-Risk or Moderate-Risk Categories:
* Risk Factor Definitions
Major Risk Factors: Microscopic Extensive PNI (defined as PNI for \>3 nerves with all involved nerves either \>0.1 mm in size and/or deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \>6 cm, or Recurrent disease status post prior Mohs
Moderate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \>0.1 mm in size)
BWH Risk factors: \>2 cm, poor differentiation, deep invasion, PNI (\>0.1 mm in size)
• BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors
High-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3
Moderate-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.
Exclusion Criteria:
* Patients receiving any other investigational agents.
Patients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Serious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Actively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.
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