Short-Course Radiation for Skin Cancer

(MOHSAHRTSS Trial)

Overseen By Christopher Anker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Vermont Medical Center

Must not be taking: Investigational agents, Cytotoxic chemotherapy

Disqualifiers: Pregnancy, Nursing, Serious comorbidities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Adults with head and neck cutaneous squamous cell carcinoma (cSCC) who've had surgery can join. High-risk patients may receive short-course radiation therapy, while moderate-risk patients might be monitored instead of getting radiation. Participants must be willing to attend follow-ups or provide blood samples for research.

Inclusion Criteria

Moderate-Risk Group (Group M): BWH T2b not meeting criteria for High-Risk

My skin cancer is confirmed and located on my head or neck.

I had Mohs surgery to remove all cancer cells within the last 70 days.

Exclusion Criteria

Patients receiving any other investigational agents

Patients pregnant or nursing

Serious medical comorbidities that would prevent participation in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

High-risk patients receive short-course radiation therapy (SCRT) over two weeks, consisting of five fractions of radiation therapy.

2 weeks

5 visits (in-person)

Active Surveillance

Moderate-risk patients undergo regular clinical exams and imaging to monitor for cancer recurrence.

2 years

Regular check-ups (frequency not specified)

Follow-up

Participants are monitored for oncologic outcomes, adverse events, and quality of life.

2 years

Treatment Details

Interventions

• MOHs Surgery
• Short-Course Radiation Therapy

Trial Overview The trial is testing if a shorter, 5-treatment radiation course over two weeks can prevent cancer from coming back in high-risk cSCC patients compared to traditional longer treatments. It's also checking if just watching and waiting is safe for those at moderate risk.

Participant Groups

Group I: Moderate-Risk Cohort Experimental Treatment 1 Intervention

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.

Group II: High-Risk Cohort Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Vermont Medical Center

Lead Sponsor

Trials

46

Recruited

25,900+