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MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer

NCT06998342 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-31

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous Squamous Cell Carcinoma (CSCC)

Interventions

RADIATION

Short course radiation

The radiation arm in this study involves Short Course Radiation Therapy (SCRT), which consists of 5 fractions delivered twice a week (either Monday/Thursday or Tuesday/Friday).

OTHER

Active Surveillance

The Active Surveillance arm (Group M) aims to monitor participants with moderate-risk cutaneous squamous cell carcinoma (cSCC) after surgical resection, without immediate intervention unless disease progression occurs. Participants will undergo regular clinical evaluations, physical exams, and skin checks to detect new lesions or signs of recurrence. Imaging, including ultrasound and CT/MRI scans, will be performed every 6 months for up to 3 years to monitor for metastasis or progression. Blood samples will be collected for future biomarker analysis to identify indicators of disease recurrence. Participants will also complete quality of life assessments using the EORTC QLQ-C30 and Skin Cancer Index (SCI) to evaluate the impact of surveillance on their daily lives. If disease progression is detected, radiation therapy may be initiated. The study will track overall survival without initiating radiation, as well as disease progression and quality of life outcomes, to determine if active s

Sponsors & Collaborators

  • University of Vermont Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2031-04-30
Completion
2031-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998342 on ClinicalTrials.gov