RecruitingNot ApplicableNCT07337161

Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma

Sponsor

David Palma

Enrollment

90 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Squamous Cell Carcinoma Cutaneous

Summary

The purpose of this study is to compare the effectiveness and side effects of stereotactic radiotherapy (5 sessions) against conventional (standard) radiotherapy (20-30 sessions) for the treatment of skin cancer involving the head and neck after surgical resection. Stereotactic radiotherapy works in the same way that conventional (standard) radiotherapy does to kill cancer cells by damaging their genetic material and stopping the cancer cells from making copies of themselves. This study will help the study doctors find out if this different approach is the same, better, or worse than the standard of care for your cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating stereotactic body radiotherapy (a precise, high-dose radiation technique) given after surgery for a specific type of skin cancer (cutaneous squamous cell carcinoma) that has spread to lymph nodes in or around the parotid gland (a salivary gland near the ear). The goal is to reduce the risk of cancer coming back. **You may be eligible if...** - You are 18 or older - You have been diagnosed with cutaneous squamous cell carcinoma (a type of skin cancer) of the head and neck - Your cancer has spread to lymph nodes in or near the parotid gland or neck - You have had surgery to remove the primary tumor and are a candidate for curative-intent treatment - Your cancer has at least one reason for adjuvant (follow-up) radiation (e.g., large tumor, nerve or vessel involvement, close margins, or multiple lymph nodes involved) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You are pregnant or breastfeeding - You have health conditions that prevent you from receiving surgery or radiation safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONSBRT

Patients 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

RADIATIONStandard Radiation

Patients 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