Comparing Stereotactic and Conventional Post-Operative Radiotherapy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
Led by David Palma · Updated on 2026-01-13
90
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and side effects of stereotactic radiotherapy compared to conventional radiotherapy for treating skin cancer in the head and neck area after surgical tumor removal. This phase II randomized trial aims to determine if the shorter, more focused stereotactic approach is as effective or better than the standard longer radiation treatment for locally advanced, node-positive cutaneous squamous cell carcinoma.
Participants will be randomly assigned to one of two groups Arm 1 receives standard radiation daily over 4 to 6.5 weeks, while Arm 2 receives ultra-hypofractionated stereotactic radiation over 5 treatments given every other weekday or twice weekly. Radiation doses vary depending on disease extent and risk areas, with adjustments made by the treating oncologist. The study will compare tumor control at 2 years, toxicity, and quality of life between the two approaches.
During the study, participants will undergo regular assessments including clinical exams, imaging, and patient questionnaires to monitor tumor control, recurrence, side effects, and quality of life up to 5 years after radiation. Researchers will track radiation-related toxicities at multiple time points during and after treatment. Patient-reported symptoms and health status will also be recorded over time to evaluate the impact of each radiation method. Total involvement may extend up to several years for long-term follow-up.
CONDITIONS
Brief Title
Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
Research Team
P
Palma
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Definitive surgery to remove primary skin tumor in head and neck
Tumor stage T1-T4 or unknown stage with positive intraparotid, peri-parotid, or cervical node
Nodal stage N1-N3
At least one indication for adjuvant radiation such as T3/T4 tumor stage, lymphovascular invasion, perineural invasion, positive or close margins, one or more positive lymph nodes, or multiple recurrences
Neoadjuvant or adjuvant immunotherapy allowed
You will not qualify if you...
Confirmed metastatic disease at diagnosis
Pregnant or breastfeeding women
Significant health issues or contraindications to surgery and radiation
History of head and neck cancer within 5 years except localized skin cancers without spread
Previous radiation to the same side parotid or neck area, with exceptions for certain previous skin cancer radiation
Need for radiation to the opposite side neck
Previous invasive cancer within 5 years unless controlled and disease free
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 to 6.5 weeks for conventional fractionation or 1 to 2 weeks for ultra-hypofractionated stereotactic radiation
Participants receive post-operative radiotherapy following surgery for cutaneous squamous cell carcinoma. They are randomized to either conventional fractionation radiation lasting 4 to 6.5 weeks or ultra-hypofractionated stereotactic radiation delivered over 5 treatments every other weekday or twice weekly.
Daily visits for 4 to 6.5 weeks or 5 visits over 1 to 2 weeks depending on assigned treatment arm
Follow-up
Duration - Up to 5 years
Participants are monitored for tumor control, recurrence, survival, toxicity, and quality of life after completing radiation treatment.
Visits at 2 weeks, 4 weeks, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2 to 5
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Stereotactic body ablative radiotherapy for reirradiation of small volume head and neck cancers is associated with prolonged survival: Large, single-institution, modern cohort study.
Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline.
Anna Likhacheva, Musaddiq Awan, Christopher A Barker...
Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.
Initial Data Pooling for Radiation Dose-Volume Tolerance for Carotid Artery Blowout and Other Bleeding Events in Hypofractionated Head and Neck Retreatments.