NCT07337161

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: David Palma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a phase II randomized trial where patients will be randomized in a 1:2 ratio to standard of care treatment with conventional fractionation PORT (Arm 1) vs. ultrahypofractionated stereotactic PORT (Arm 2). Patients will be stratified by pathologic nodal status (pN1 vs. pN2-pN3) per the American Joint Committee on Cancer (AJCC) 8th edition staging and use of immunotherapy (classified as neoadjuvant immunotherapy (with or without adjuvant immunotherapy) vs. planned for adjuvant immunotherapy only vs. no immunotherapy. Patients randomized to Arm 2 will be also compared to historical control data for primary endpoint of tumor local control at 2-years. The objective of this study is to assess the clinical efficacy, toxicity and QOL of ultra-hypofractionated SABR compared to conventional fractionation for adjuvant radiation following resection of locally advanced, node-positive cutaneous SCC of the head and neck. Primary endpoint \- Tumor control within the irradiated field at 2 years following adjuvant radiation completion defined as absence of clinical, radiographic or biopsy-proven recurrence within the irradiated field Secondary endpoints * Regional recurrence * Disease-free survival (DFS) * Overall survival (OS) * Rate of salvage treatment (surgery in the ipsilateral neck) and freedom from unsalvageable recurrence in the ipsilateral parotid gland or neck * Radiation-associated toxicity based on the Common Terminology Criteria for Adverse Events(CTCAE) version 5.0 * Patient-reported outcomes using the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) and the EuroQOL 5-Dimension 5-Level (EQ-5D-5L) questionnaires

Conditions

• Cutaneous
• Head and Neck Cancer Squamous Cell Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-10-21
• Primary completion: 2030-09-01
• Completion: 2035-09-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Canada