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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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
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
Verspeeten Family Cancer Centre
London, Ontario, Canada
RECRUITINGTumor control
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
Time frame: 2 years
Regional recurrence
calculated as time from randomization to evidence of disease recurrence anywhere in the ipsilateral parotid gland or neck
Time frame: 2 years
Disease-free survival (DFS)
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.
Time frame: 2 years
Overall survival
calculated as time from randomization to death from any cause, or last follow-up, whichever occurs first.
Time frame: 2 years
Rate of salvage surgery
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.
Time frame: 2 years
Radiation-associated toxicity
Radiation-associated toxicity based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade 2 or higher.
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.
Patient-reported outcomes
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.
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
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.
Time frame: Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
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