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New treatment option for Cutaneous Squamous Cell Carcinoma (CSCC)
Official title MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer
ClinicalTrials.gov ID: NCT06998342
What this study is testing
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically confirmed cutaneous squamous cell carcinoma of the head \& neck region, defined as extending from vertex of head to supraclavicular...
- Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Burlington, Vermont, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burlington, Vermont, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.