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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for skin cancer, specifically cutaneous squamous cell carcinoma (cSCC) on the head and neck. It aims to determine if a short-course radiation therapy, consisting of five treatments over two weeks, can prevent cancer recurrence in individuals with high-risk cSCC. For those with moderate-risk cSCC, the trial tests whether regular check-ups can safely monitor the cancer instead of using radiation. Individuals who have undergone MOHs Surgery for cSCC and possess certain risk factors that classify their cancer as high or moderate risk may be suitable candidates. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in cancer care.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications, like systemic chemotherapy or immunosuppressive therapy, while participating. If you're on these types of medications, you may need to stop them to join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that short-course radiation therapy (SCRT) is generally safe for treating skin cancer. In one study, about 80% of patients who received high-dose, short-course radiation achieved good cosmetic results, comparable to those from longer treatments. Another study found that short radiation courses for head and neck cancer were safe and improved symptom management and quality of life.

Additionally, short-course radiation for skin cancers like squamous cell carcinoma (SCC) has proven very effective in preventing recurrence. One report noted a 92.7% success rate in stopping SCC from returning over five years.

While these results are encouraging, every treatment can have side effects. However, based on this evidence, SCRT appears to be a well-tolerated option for skin cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for skin cancer, like long-course radiation therapy, require many weeks of treatment, often involving 30 or more sessions. However, the new approach called Short-Course Radiation Therapy (SCRT) for high-risk patients aims to complete treatment in just five sessions over two weeks. This not only reduces the treatment burden significantly but also offers a chance for quicker recovery with potentially fewer side effects. For moderate-risk patients, researchers are exploring whether active surveillance, instead of immediate radiation, could safely monitor the condition, potentially sparing patients from unnecessary treatments. Researchers are excited about these approaches because they may offer effective cancer control while improving quality of life and reducing treatment time.

What evidence suggests that short-course radiation therapy could be an effective treatment for high-risk cutaneous squamous cell carcinoma?

Research has shown that radiation therapy effectively treats head and neck skin cancer known as squamous cell carcinoma (cSCC). One study found that higher doses of radiation therapy successfully controlled the disease. Another study reported that about 92.7% of patients with this cancer type prevented its growth for five years. In this trial, high-risk patients will undergo short-course radiation therapy (SCRT), aiming to achieve similar results with fewer treatments, making it less demanding than traditional methods. This suggests SCRT could be a promising option for high-risk patients by reducing treatment time while maintaining effectiveness. Meanwhile, moderate-risk patients will undergo regular clinical exams and imaging without receiving adjuvant radiation therapy. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10996410/

A SHort course Accelerated RadiatiON therapy (SHARON) ... Twelve patients reported an improvement or resolution of baseline symptoms (overall palliative response rate: 85.8%). Nine and seven patients underwent to two ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524005430

Outcomes With Radiation Therapy as Primary Treatment ... Radiation therapy can effectively treat unresectable head and neck cutaneous SCC. It has a high response rate, with higher doses producing longer disease ...

3. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(24)00543-0/abstract

Outcomes With Radiation Therapy as Primary Treatment ... Overall survival at 6 months was 83% and 89%, and by 24 months 31% and 65%, respectively. Conclusion. RT is an efficacious treatment that can be ...

4. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13864-z

Updated results of 3050 non-melanoma skin cancer (NMSC ... Hernández-Machin et al. reported 5-year absolute LC rates of 94.4% for BCC lesions and 92.7% for SCC lesions. With these results, the authors ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/65/9/1450

Effectiveness and Patient Experiences of Rhenium Skin ... This preliminary analysis of the EPIC-Skin study indicates that Rhenium SCT is safe and effective for the treatment of BCC and SCC and is associated with ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406822005197

Radiotherapy for older adults with facial non-melanoma ... Radiotherapy for older adults with facial non-melanoma skin cancer: Effectiveness in patients aged 80 and older - ScienceDirect.

7. pennstatehealthnews.org pennstatehealthnews.org/2018/01/short-course-radiation-treatment-is-safe-and-effective-for-skin-cancer/

Short-course radiation treatment is safe and effective for ... About 80 percent of patients receiving high-dose, short-course therapies had good cosmetic results, similar to longer-course treatments with ...

8. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(19)30340-1/pdf

Current Role of Radiotherapy in Non-melanoma Skin Cancer Margin status is a well-documented risk factor for patients developing local relapse, with data that local adjuvant radiotherapy can decrease the risk of local ...