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

January 6, 2026 updated by: David Palma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Verspeeten Family Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor control
Time Frame: 2 years
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regional recurrence
Time Frame: 2 years
calculated as time from randomization to evidence of disease recurrence anywhere in the ipsilateral parotid gland or neck
2 years
Disease-free survival (DFS)
Time Frame: 2 years
calculated as time from randomization to evidence of recurrence at any site, death from any cause, or last follow-up, whichever occurs first. New primary cutaneous SCC of the head or neck will not be counted towards DFS events.
2 years
Overall survival
Time Frame: 2 years
calculated as time from randomization to death from any cause, or last follow-up, whichever occurs first.
2 years
Rate of salvage surgery
Time Frame: 2 years
calculated as time from randomization to salvage surgery in the ipsilateral treated neck. Freedom from unsalvageable parotid/neck recurrence will be documented as time from randomization to evidence of recurrence in the ipsilateral parotid gland or neck that cannot be salvaged (either surgery or radiation), or last follow-up, whichever occurs first.
2 years
Radiation-associated toxicity
Time Frame: Baseline, during treatment, 2 weeks post treatment, 4 weeks post treatment, 3, 12, 18, 24 months post treatment, and yearly from years 2-5 after the end of radiation.
Radiation-associated toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade 2 or higher.
Baseline, during treatment, 2 weeks post treatment, 4 weeks post treatment, 3, 12, 18, 24 months post treatment, and yearly from years 2-5 after the end of radiation.
Patient-reported outcomes
Time Frame: Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
Patient-reported outcomes using the MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) questionaries. The head and neck cancer specific symptoms are rated on a 0-10 scale to indicate the presence and severity of the symptoms. Lower scores represent better functioning and quality of life.
Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
Patient Reported Outcome
Time Frame: Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
Patient reported outcome using the Euro QOL 5-Dimension 5-Level (EQ-5D-5L) questionnaire. EQ-5D-5L is a widely used questionnaire for measuring health-related quality of life, assessing five key health areas (Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression) with five levels of severity (no to extreme problems) and a self-rated health scale (EQ-VAS) for overall well-being, helping evaluate treatments and health interventions.
Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Palma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2035

Study Registration Dates

First Submitted

August 28, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5201
  • 15521 (Other Identifier: London Health Science Centre (LHSCRI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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