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

NCT07337161 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

  • Cutaneous
  • Head and Neck Cancer Squamous Cell Carcinoma

Interventions

RADIATION

SBRT

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

RADIATION

Standard 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

Sponsors & Collaborators

  • David Palma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-21
Primary Completion
2030-09-01
Completion
2035-09-01

Countries

  • Canada

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 NCT07337161 on ClinicalTrials.gov