MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer
NCT ID: NCT06998342
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2025-06-30
2031-05-31
Brief Summary
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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.
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Detailed Description
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High-Risk Cohort (Short-Course Radiation Therapy - SCRT) Patients classified as high risk will undergo SCRT, consisting of five fractions of radiation therapy over a two-week period. This approach aims to provide effective local control while minimizing treatment burden compared to conventional long-course radiation therapy (typically 30+ fractions over six weeks). The study will assess the efficacy, safety, and long-term outcomes of SCRT, including recurrence rates, toxicity profiles, and patient-reported quality of life.
Moderate-Risk Cohort (Active Surveillance) Patients meeting moderate-risk criteria will not receive adjuvant radiation therapy but will instead be monitored through regular clinical exams and imaging. This arm evaluates whether active surveillance is a safe alternative to radiation in this population by tracking recurrence rates and overall survival.
Study Design and Assessments Participants will be followed for oncologic outcomes (local, regional, and distant recurrence rates), adverse events, functional outcomes, and patient-reported quality of life. Optional blood sample collection will allow for biomarker analysis and potential future translational research.
By stratifying patients based on risk, this trial aims to refine post-surgical management of head and neck cSCC, potentially reducing unnecessary radiation exposure in moderate-risk patients while ensuring effective treatment for high-risk individuals.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Moderate-Risk Cohort
Patients meeting moderate-risk criteria will not receive adjuvant radiation therapy but will instead be monitored through regular clinical exams and imaging. This arm evaluates whether active surveillance is a safe alternative to radiation in this population by tracking recurrence rates and overall survival.
Active Surveillance
The Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT/MRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s
High-Risk Cohort
Patients classified as high risk will undergo SCRT, consisting of five fractions of radiation therapy over a two-week period. This approach aims to provide effective local control while minimizing treatment burden compared to conventional long-course radiation therapy (typically 30+ fractions over six weeks). The study will assess the efficacy, safety, and long-term outcomes of SCRT, including recurrence rates, toxicity profiles, and patient-reported quality of life.
Short course radiation
The radiation arm in this study involves Short Course Radiation Therapy (SCRT), which consists of 5 fractions delivered twice a week (either Monday/Thursday or Tuesday/Friday).
Active Surveillance
The Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT/MRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s
Interventions
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Short course radiation
The radiation arm in this study involves Short Course Radiation Therapy (SCRT), which consists of 5 fractions delivered twice a week (either Monday/Thursday or Tuesday/Friday).
Active Surveillance
The Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT/MRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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University of Vermont Medical Center
OTHER
Responsible Party
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Christopher Anker
Radiation Oncologist. Professor, Radiation-Oncology
Locations
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University of Vermont Medical Center
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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UVMCC2410/STUDY00003513
Identifier Type: -
Identifier Source: org_study_id
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