Study on Mohs Surgery and Short-Course Radiation Therapy with Follow-Up for Head and Neck Squamous Cell Skin Cancer

Sponsor: University of Vermont Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06998342

Provider View

This clinical trial is exploring whether short-course radiation therapy can effectively treat high-risk squamous cell skin cancer in the head and neck area after surgery, and if regular monitoring is a safe option for moderate-risk cases.

Patient Parameters

Program Overview

The aim of this study is to find out if a short course of radiation therapy (5 treatments over 2 weeks) can prevent cancer from coming back in patients with high-risk head and neck squamous cell skin cancer after surgery. It also looks at whether moderate-risk patients can be safely monitored with regular check-ups instead of receiving radiation. Researchers will compare the effectiveness of short-course radiation therapy to past data on longer radiation treatments and assess the safety of active surveillance by tracking cancer recurrence rates.

Description

This study is testing two different approaches for treating squamous cell skin cancer of the head and neck after surgery, based on the patient's risk level.

For the High-Risk Group, patients will receive short-course radiation therapy (SCRT), which involves five radiation treatments over two weeks. This method aims to control the cancer effectively while reducing the treatment burden compared to traditional longer radiation courses. The study will evaluate how well this approach works, its safety, and its impact on patients' quality of life.

For the Moderate-Risk Group, patients will not receive additional radiation therapy but will be closely monitored through regular check-ups and imaging tests. This part of the study will determine if active surveillance is a safe alternative to radiation by observing cancer recurrence and survival rates.

Participants will be followed to track cancer outcomes, any side effects, and their quality of life. Optional blood samples may be collected for future research on biomarkers. By categorizing patients based on their risk, the study aims to improve post-surgery management of head and neck squamous cell skin cancer, potentially reducing unnecessary radiation for moderate-risk patients while ensuring effective treatment for those at high risk.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell skin cancer in the head and neck area, from the top of the head to the collarbone.
  • Underwent Mohs surgery, with or without additional surgery, to remove all cancer within 70 days before joining the study.
  • Cancer stage must be T1-T3 N0 M0, based on recent medical exams and imaging tests.
  • Must fit into either the High-Risk or Moderate-Risk categories based on specific risk factors:
    • High-Risk: Major risk factors like large tumor size, nerve involvement, or recurrent cancer.
    • Moderate-Risk: Factors like poor differentiation or certain tumor sizes.
  • Group H (High-Risk): Any 1 major risk factor or 2-3 moderate risk factors.
  • Group M (Moderate-Risk): Specific moderate-risk factors not meeting high-risk criteria.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • Pregnant or nursing women due to potential risks to the baby.
  • Serious health conditions that would prevent participation, as determined by a doctor.
  • Previous chemotherapy for this cancer (other cancers are okay).
  • Previous radiation in the same area that would overlap with study treatment.
  • Currently on certain chemotherapy or immune-related treatments.

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