Stereotactic Radiotherapy for Skin Cancer
(SPRINT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two types of radiotherapy for skin cancer on the head and neck: stereotactic radiotherapy (a focused 5-session treatment known as Stereotactic Body Radiotherapy or SBRT) and conventional radiotherapy (a longer 20-30 session treatment). The researchers aim to determine which method is more effective and has fewer side effects after surgery. The trial seeks participants who have had surgery for skin cancer in the head or neck and require subsequent radiation treatment. Eligible participants must have a biopsy-confirmed skin cancer and have undergone surgery for a tumor in the head or neck region. This study helps doctors identify the best treatment option for future patients. As an unphased trial, it offers participants the chance to contribute to research that may enhance treatment options for future patients.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, neoadjuvant or adjuvant immunotherapy is allowed, which suggests some medications may be continued. It's best to discuss your specific medications with the trial team.
What prior data suggests that stereotactic radiotherapy is safe for treating skin cancer?
Research has shown that stereotactic body radiotherapy (SBRT) is generally easy for patients to handle. In previous studies, most side effects were mild, with only about 3% of patients experiencing more serious issues. While some people might feel a bit uncomfortable, the treatment is usually safe.
SBRT treats skin cancer by directly targeting cancer cells and preventing them from spreading. Researchers are also testing this treatment with other therapies, and early results have been promising for both safety and effectiveness.
Overall, evidence suggests that SBRT is a safe option for many people, and serious side effects are rare. Prospective trial participants should discuss any concerns with their healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for skin cancer because it offers a more precise and quicker way to target tumors compared to traditional radiation therapy. Unlike conventional methods that can take weeks, SBRT delivers high doses of radiation in just five sessions, which might lead to less damage to surrounding healthy tissue and fewer side effects. This approach could also be more effective for treating areas of residual disease and at-risk nodal levels, making it a promising option for patients with complex cases of skin cancer.
What evidence suggests that stereotactic radiotherapy could be an effective treatment for skin cancer?
Research has shown that stereotactic body radiotherapy (SBRT) effectively treats certain cancers, including skin cancer in the head and neck area. Studies have found that SBRT can control tumors locally in 80-90% of cases for some conditions. Specifically, for head and neck skin cancer, SBRT has achieved good results. It delivers precise, high doses of radiation to cancer cells, damaging their DNA and stopping their growth. Patients have experienced fewer side effects compared to more traditional treatments. In this trial, participants in the SBRT arm will receive ultra-hypofractionated stereotactic radiation, which may offer a promising option for treating skin cancer after surgery.12678
Are You a Good Fit for This Trial?
This trial is for adults over 18 with certain stages of skin cancer in the head and neck area, who have had surgery to remove it. They must be able to understand English, give informed consent, and have a performance status that allows them to carry out daily activities with some limitations.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either conventional fractionation radiation over 4 to 6.5 weeks or ultra-hypofractionated stereotactic radiation over 5 treatments
Follow-up
Participants are monitored for tumor control, regional recurrence, disease-free survival, overall survival, and radiation-associated toxicity
What Are the Treatments Tested in This Trial?
Interventions
- Stereotactic Body Radiotherapy (SBRT)
Trial Overview
The study compares stereotactic radiotherapy (5 sessions) versus conventional radiotherapy (20-30 sessions) after surgical removal of skin cancer in the head and neck. It aims to determine if this new approach is as effective or better than standard treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients in Arm 2 will receive ultra-hypofractionated stereotactic radiation over 5 treatments delivered every other weekday or twice weekly as follows: * 40 to 42.5 Gy in 5 fractions: any areas of gross residual disease, or gross PNI on imaging * 32.5 to 35 Gy in 5 fractions: microscopic areas at risk including positive margin and/or ENE * 30 Gy in 5 fractions: entire operative bed including areas of primary tumor and involved nodes and dissected cervical nodal levels * 27.5 to 30 Gy 5 fractions: at risk undissected cervical nodal levels adjacent to pathologically involved nodal levels, based on the discretion of the treating oncologist
Patients in Arm 1 will receive daily conventional fractionation radiation over 4 or 6-6.5 weeks based on the treating oncologist's discretion. The below dose levels are recommended in the following clinical scenarios but may be modified per institutional standards: 20-fraction regimen or 30 to 33-fraction regimen
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Palma
Lead Sponsor
Citations
Clinical outcomes and efficacy of stereotactic body radiation ...
Patients who were treated with SBRT who had ≤5 metastatic lesions at first recurrence had a superior 1 year OS of 100 vs50% for those with >5 lesions (Figure 2B) ...
Success Rate and Survival After Stereotactic Radiotherapy
SBRT is highly effective, demonstrating two-year success rates between 80% and 90% for some conditions and achieving local tumor control rates ...
Stereotactic Body Radiation Therapy for Periorbital Tumors
This study assesses the efficacy and toxicity of stereotactic body radiation therapy (SBRT) as a treatment option in the new paradigm shift towards 'eye- ...
Stereotactic body radiotherapy for head and neck skin cancer
Aim. To report outcomes of Stereotactic Body Radiotherapy (SBRT) for head and neck skin cancer (HNSC) patients treated at a high-volume center.
Stereotactic body radiotherapy as a viable treatment on ...
SBRT demonstrated efficacy in managing melanoma patients with extracranial oligometastases and showed an overall low toxicity profile.
The Role of Stereotactic Radiotherapy in the Management of ...
Therapy related adverse events were mostly tolerable with only 3% of Grade 3 toxicity. We concluded that stereotactic radiotherapy and ...
Radiotherapy in Combination With Atezolizumab in Locally ...
This phase I trial tests the safety and side effects radiotherapy in combination with atezolizumab in treating patients with cutaneous squamous cell cancer ...
Case Report: Stereotactic body radiation treatment for ...
In this report, we describe two cases of one patient with metastatic melanoma and the other with metastatic Merkel cell carcinoma (MCC) who were ...
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