Cutaneous Squamous Cell Carcinoma (CSCC)Phase 2MOHSAHRTSSNCT06998342
MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer
A Phase 2 study testing Short course radiation and Active Surveillance in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by University of Vermont Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma (CSCC)
- What is being tested?
- Short course radiation and Active Surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2025to May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
Christopher Anker, MD, 7739804380, chris.anker@uvmhealth.org
Ben Briggs, QA Officer, (802) 656-2021, benjamin.briggs@uvmhealth.org
About this study
Official title: MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)
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:
Read more
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.
Read the detailed description
This clinical trial investigates two approaches for managing cutaneous squamous cell carcinoma (cSCC) of the head and neck following surgical resection, based on patient risk stratification. The study evaluates short-course radiation therapy (SCRT) as a treatment for high-risk cSCC and active surveillance as a potential alternative to radiation therapy for moderate-risk cSCC.
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
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Being tested
- Short course radiation, Active Surveillance
- Keywords
- Cutaneous Squamous Cell Carcinoma, Head and Neck Cancer, Neoadjuvant Therapy, Immunotherapy, Surgical Oncology, Clinical Trial, Radiation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiationRadiation
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 SurveillanceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Risk Cohort | Experimental | 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. Receives: Other: Active Surveillance |
| High-Risk Cohort | Experimental | 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. Receives: Radiation: Short course radiation; Other: Active Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring the Efficacy of Adjuvant Hypofractionated Radiation Therapy in High-Risk cSCC Head and Neck Patients: A Comparison of 2-Year Locoregional Recurrence Rates
To explore the potential efficacy of adjuvant hypofractionated radiation therapy (SCRT) in high-risk cutaneous squamous cell carcinoma (cSCC) head and neck patients by examining the 2-year locoregional recurrence rate (LRR) and comparing it to historical controls who received standard long-course radiation therapy (LCRT). Considering the variability in LRR among patients eligible for SCRT, the researchers aim to investigate whether a 2-year LRR <25% could be achieved.
Measured: 2 years
Secondary outcomes (18)
2-Year Locoregional Recurrence Rate (LRR) in Moderate-Risk SCC Patients
To assess the 2-year rate of locoregional recurrence (LRR) in moderate-risk patients undergoing active surveillance, compared to historical controls. Unit of Measure: Percentage of participants with locoregional recurrence.
Measured: 2 years
2-Year Overall Survival (OS) in High-Risk SCC Patients Receiving SCRT
To evaluate overall survival at 2 years in high-risk patients treated with short-course radiation therapy (SCRT), compared to historical controls who received long-course radiation therapy (LCRT). Unit of Measure: Percentage of participants alive at 2 years.
Measured: 2 years
Health-Related Quality of Life (HRQoL) in High-Risk SCC Patients as Measured by EORTC QLQ-C30
To assess overall health-related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in patients receiving SCRT or active surveillance. This validated questionnaire includes subscales for physical, emotional, and social functioning, among others. Unit of Measure: Score on scale from 0 to 100; higher scores on functioning scales and global health indicate better outcomes; higher scores on symptom scales indicate worse symptoms.
Measured: 3 years
2-Year Overall Survival (OS) in Moderate-Risk SCC Patients
To assess overall survival (OS) at 2 years in moderate-risk patients undergoing active surveillance. OS is defined as time from surgery to death from any cause. Unit of Measure: Percentage of participants alive at 2 years.
Measured: 2 years
2-Year Disease-Specific Survival (DSS) in Moderate-Risk SCC Patients
To assess disease-specific survival (DSS) at 2 years. DSS is defined as time from surgery to death attributed to cutaneous squamous cell carcinoma (cSCC). Unit of Measure: Percentage of participants who survive without dying from cSCC
Measured: 2 years
Local Recurrence Rate (LR) in Moderate-Risk SCC Patients
To assess the incidence of local tumor recurrence in moderate-risk patients undergoing active surveillance. To assess the incidence of local tumor recurrence in moderate-risk patients undergoing active surveillance.
Measured: 2 years
Regional Recurrence Rate (RR) in Moderate-Risk SCC Patients
To assess the incidence of regional tumor recurrence (e.g., nodal) in moderate-risk patients. Unit of Measure: Percentage of participants with regional recurrence
Measured: 2 years
Distant Metastasis Rate (DMR) in Moderate-Risk SCC Patients
To assess the incidence of distant metastasis at 2 years. Unit of Measure: Percentage of participants with distant metastasis
Measured: 2 years
Total Relapse Rate (TRR) in Moderate-Risk SCC Patients
To assess the 2-year total relapse rate (local, regional, or distant) in moderate-risk patients. Unit of Measure: Percentage of participants with any form of relapse
Measured: 2 years
Rate of Resectability at Recurrence in Moderate-Risk SCC Patients
To assess the proportion of participants with resectable disease upon recurrence. Unit of Measure: Percentage of recurrences deemed resectable
Measured: 2 years
2-Year Disease-Specific Survival (DSS) in High-Risk SCC Patients Receiving SCRT
To evaluate disease-specific survival at 2 years in high-risk patients treated with SCRT, compared to historical controls. DSS is defined as death due to cSCC. Unit of Measure: Percentage of participants surviving without death from cSCC.
Measured: 2 years
Local Recurrence Rate (LR) in High-Risk SCC Patients Receiving SCRT
To evaluate the local recurrence rate at 2 years in high-risk patients treated with SCRT, compared to historical controls treated with LCRT. Unit of Measure: Percentage of participants with local recurrence.
Measured: 2 years
Regional Recurrence Rate (RR) in High-Risk SCC Patients Receiving SCRT
To evaluate the regional recurrence rate at 2 years in high-risk patients treated with SCRT, compared to historical controls treated with LCRT. Unit of Measure: Percentage of participants with regional recurrence.
Measured: 2 years
Distant Metastasis Rate (DMR) in High-Risk SCC Patients Receiving SCRT
To evaluate the distant metastasis rate at 2 years in high-risk patients treated with SCRT, compared to historical controls. Unit of Measure: Percentage of participants with distant metastases
Measured: 2 years
Unit of Measure: Percentage of participants with distant metastases
To evaluate the total relapse rate at 2 years (local, regional, or distant) in high-risk patients treated with SCRT, compared to historical controls treated with LCRT. Unit of Measure: Percentage of participants with any recurrence.
Measured: 2 years
Rate of Resectability at Recurrence in High-Risk SCC Patients Receiving SCRT
To assess the proportion of patients whose recurrence was considered surgically resectable. To assess the proportion of patients whose recurrence was considered surgically resectable.
Measured: 2 years
Skin Cancer-Specific Quality of Life in High-Risk SCC Patients as Measured by the Skin Cancer Index (SCI)
To evaluate quality of life specific to skin cancer using the Skin Cancer Index (SCI), which includes domains such as emotional, social, and appearance-related concerns. Unit of Measure: Score on scale from 0 to 100; higher scores indicate better quality of life.
Measured: 3 years
Patient-Reported Cancer Care Burden as Measured by the Patient Experience Survey (PES)
To assess cancer care-related burdens such as travel, cost, and logistical challenges using the Patient Experience Survey (PES), a custom questionnaire including both Likert-scale and yes/no questions. Unit of Measure: Percentage of patients reporting specific concerns (e.g., % worried about cost, % concerned about transportation).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start4 Jun 2025
- Primary completionApr 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell Carcinoma (CSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Anker, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998342
- Sponsor's protocol ID
- UVMCC2410/STUDY00003513
- Acronym
- MOHSAHRTSS
- Status last verified
- May 2026
- First submitted
- 7 May 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)
- ClinicalTrials.gov ID
- NCT06998342
- Acronym / sponsor ID
- MOHSAHRTSS / UVMCC2410/STUDY00003513
- Conditions
- Cutaneous Squamous Cell Carcinoma (CSCC)
- Keywords
- Cutaneous Squamous Cell Carcinoma, Head and Neck Cancer, Neoadjuvant Therapy, Immunotherapy, Surgical Oncology, Clinical Trial, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial investigates two approaches for managing cutaneous squamous cell carcinoma (cSCC) of the head and neck following surgical resection, based on patient risk stratification. The study evaluates short-course radiation therapy (SCRT) as a treatment for high-risk cSCC and active surveillance as a potential alternative to radiation therapy for moderate-risk cSCC.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-Risk Cohort | Experimental | Other: Active SurveillancePatients 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. |
| High-Risk Cohort | Experimental | Radiation: Short course radiation, Other: Active SurveillancePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- Risk Factors fitting either the High-Risk or Moderate-Risk Categories:
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course radiationThe 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). | Radiation | High-Risk Cohort |
| Active SurveillanceThe 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 | Other | High-Risk Cohort, Moderate-Risk Cohort |
Primary outcome
Exploring the Efficacy of Adjuvant Hypofractionated Radiation Therapy in High-Risk cSCC Head and Neck Patients: A Comparison of 2-Year Locoregional Recurrence Rates
Time frame: 2 years
To explore the potential efficacy of adjuvant hypofractionated radiation therapy (SCRT) in high-risk cutaneous squamous cell carcinoma (cSCC) head and neck patients by examining the 2-year locoregional recurrence rate (LRR) and comparing it to historical controls who received standard long-course radiation therapy (LCRT). Considering the variability in LRR among patients eligible for SCRT, the researchers aim to investigate whether a 2-year LRR <25% could be achieved.
18 secondary outcomes
2-Year Locoregional Recurrence Rate (LRR) in Moderate-Risk SCC Patients
Time frame: 2 years
2-Year Overall Survival (OS) in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Health-Related Quality of Life (HRQoL) in High-Risk SCC Patients as Measured by EORTC QLQ-C30
Time frame: 3 years
2-Year Overall Survival (OS) in Moderate-Risk SCC Patients
Time frame: 2 years
2-Year Disease-Specific Survival (DSS) in Moderate-Risk SCC Patients
Time frame: 2 years
Local Recurrence Rate (LR) in Moderate-Risk SCC Patients
Time frame: 2 years
Regional Recurrence Rate (RR) in Moderate-Risk SCC Patients
Time frame: 2 years
Distant Metastasis Rate (DMR) in Moderate-Risk SCC Patients
Time frame: 2 years
Total Relapse Rate (TRR) in Moderate-Risk SCC Patients
Time frame: 2 years
Rate of Resectability at Recurrence in Moderate-Risk SCC Patients
Time frame: 2 years
2-Year Disease-Specific Survival (DSS) in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Local Recurrence Rate (LR) in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Regional Recurrence Rate (RR) in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Distant Metastasis Rate (DMR) in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Unit of Measure: Percentage of participants with distant metastases
Time frame: 2 years
Rate of Resectability at Recurrence in High-Risk SCC Patients Receiving SCRT
Time frame: 2 years
Skin Cancer-Specific Quality of Life in High-Risk SCC Patients as Measured by the Skin Cancer Index (SCI)
Time frame: 3 years
Patient-Reported Cancer Care Burden as Measured by the Patient Experience Survey (PES)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No. Anonymized patient related data will be incorporated into publications and will be made available to other investigators at reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Short course radiation and Active Surveillance in people with Cutaneous Squamous Cell Carcinoma (CSCC), run by University of Vermont Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Anker, MD ((802) 656-2021, chris.anker@uvmhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploring the Efficacy of Adjuvant Hypofractionated Radiation Therapy in High-Risk cSCC Head and Neck Patients: A Comparison of 2-Year Locoregional Recurrence Rates (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.