Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
NCT ID: NCT07337161
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-10-21
2035-09-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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David Palma
OTHER
Responsible Party
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David Palma
Professor, Schulich School of Medicine & Dentistry, University of Western Ontario
Locations
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Verspeeten Family Cancer Centre
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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15521
Identifier Type: OTHER
Identifier Source: secondary_id
5201
Identifier Type: -
Identifier Source: org_study_id
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