NCT06998342 MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer
| NCT ID | NCT06998342 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Vermont Medical Center |
| Condition | Cutaneous Squamous Cell Carcinoma (CSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-06-04 |
| Primary Completion | 2031-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2025-06-04 with a primary completion date of 2031-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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-course radiation therapy and attend follow-up visits. Moderate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence. Optionally provide blood samples for future biomarker research.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06998342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Squamous Cell Carcinoma (CSCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06998342 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06998342 currently recruiting?
Yes, NCT06998342 is actively recruiting participants. Contact the research team at chris.anker@uvmhealth.org for enrollment information.
Where is the NCT06998342 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT06998342 clinical trial?
NCT06998342 is sponsored by University of Vermont Medical Center. The trial plans to enroll 24 participants.