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NCT06998342

PHASE2

MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer

Sponsor: University of Vermont Medical Center

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06

Completion Date

2031-05

Last Updated

2025-05-31

Healthy Volunteers

Conditions

Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

RADIATION

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).

OTHER

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

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.

Locations (1)

University of Vermont Medical Center

Burlington, Vermont, United States