Recruiting

Stereotactic Radiotherapy vs. Conventional Radiotherapy

Sponsor:

David Palma

Code:

NCT07337161

Conditions

Cutaneous

Head and Neck Cancer Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBRT

Standard Radiation

Study Details

Brief 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

Study ID

NCT07337161

Start date

Oct 21, 2025

Status verified date

Jan, 2026

Completion date

Sep 1, 2035

Anticipated

Primary completion date

Sep 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria

  • Age ≥ 18 years
  • Patient able to provide informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Patient is a candidate for curative intent treatment
  • Patient is able to comprehend English adequately to complete patient reported outcome questionnaires
  • Biopsy-confirmed cutaneous SCC
  • Definitive resection of a primary cutaneous tumor within the head and neck
  • Tumor stage T1-T4 (AJCC 8th edition); or tumor stage unknown (T0/Tx) with a positive intraparotid, peri-parotid or cervical node that is assumed to be from a head and neck cutaneous SCC by the treating oncologist
  • Nodal stage N1-N3 (AJCC 8th edition)
  • At least 1 indication for adjuvant radiation, including:

  • T3 or T4 tumor stage
  • Lymphovascular invasion (LVI)
  • Perineural invasion (PNI)
  • Positive or close (≤ 3 mm) margin
  • ≥ 1 positive intraparotid, peri-parotid or cervical lymph node
  • Multiple local recurrences or multi-focal disease
  • Neoadjuvant or adjuvant immunotherapy is allowed

Exclusion criteria

  • Definite metastatic disease at diagnosis
  • Pregnant or breastfeeding women
  • Significant health conditions or contraindications to receiving surgery and radiation
  • History of previous head and neck cancer within 5 years, except for localized skin cancers (i.e. no nodal or distant spread)
  • Prior head and neck radiation involving the ipsilateral parotid or neck. However, prior radiation to the index skin cancer that has led to the parotid nodal disease being treated on this trial is allowed, as long as there is no overlap, or inconsequential overlap, in the judgement of the treating oncologist.
  • Indications for contralateral neck radiation (i.e. contralateral or bilateral lymph nodes)
  • Previous invasive malignancy within 5 years, unless controlled with no evidence of disease

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1: Control

Patients in Arm 1 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

experimental: Arm 2: SBRT arm

Patients in Arm 2 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

Interventions

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

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

Primary outcome measure

  • Tumor control [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Palma

519-685-8500david.palma@lhsc.on.ca

Locations

Verspeeten Family Cancer Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

David Palma, MD, MSc, PhD, FRCPC

866-797-0000david.palma@lhsc.on.ca

More Information

Sponsor

David Palma

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • skin
  • head and neck
  • radiation
  • SBRT
  • SABR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Palma on 2026-01-13.