CutaneousSPRINTNCT07337161
Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
A study testing SBRT and Standard Radiation in people with Cutaneous and Head and Neck Cancer Squamous Cell Carcinoma, run by David Palma at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous, Head and Neck Cancer Squamous Cell Carcinoma
- What is being tested?
- SBRT and Standard Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 21 Oct 2025to 1 Sep 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
David Palma, MD, MSc, PhD, FRCPC, 866-797-0000, david.palma@lhsc.on.ca
About this study
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.
Read the 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
- Being tested
- SBRT, Standard Radiation
- Keywords
- skin, head and neck, radiation, SBRT, SABR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
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 RadiationRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control | Active comparator | 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 Receives: Radiation: Standard Radiation |
| Arm 2: SBRT arm | Experimental | 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 Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor 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
Measured: 2 years
Secondary outcomes (7)
Regional recurrence
calculated as time from randomization to evidence of disease recurrence anywhere in the ipsilateral parotid gland or neck
Measured: 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.
Measured: 2 years
Overall survival
calculated as time from randomization to death from any cause, or last follow-up, whichever occurs first.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start21 Oct 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Palma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Palma, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337161
- Sponsor's protocol ID
- 5201
- Other IDs
- 15521
- Acronym
- SPRINT
- Status last verified
- Jan 2026
- First submitted
- 28 Aug 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Culbert M, Bidermann G, Wallace AS. Decisional preferences and satisfaction with short-course radiation for breast cancer. JCO. 2018;36(30_suppl):193-193. doi:10.1200/JCO.2018.36.30_suppl.193
National Comprehensive Cancer Network Squamous Cell Skin Cancer (version 1.2024). https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed 24 August 2024.
National Cancer Institute-Common Toxicity Criteria Adverse Events Version 5. Published 2017. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Refer ence_8.5x11.pdf. Accessed 25 August 2024.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Hatswell A, Freemantle N, Baio G, Lesaffre E, van Rosmalen J. Summarising salient information on historical controls: A structured assessment of validity and comparability across studies. Clin Trials. 2020 Dec;17(6):607-616. doi: 10.1177/1740774520944855. Epub 2020 Sep 21.
PubMed 32957804Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976 Mar;29(3):175-88. doi: 10.1016/0021-9681(76)90044-8. No abstract available.
PubMed 770493Ringash J, O'Sullivan B, Bezjak A, Redelmeier DA. Interpreting clinically significant changes in patient-reported outcomes. Cancer. 2007 Jul 1;110(1):196-202. doi: 10.1002/cncr.22799.
PubMed 17546575Yao JJ, Zhou GQ, Jin YN, Zhang WJ, Lin L, Yu XL, Shao JY, Ma J, Sun Y. Predictors of Mastoiditis after Intensity-Modulated Radiotherapy in Nasopharyngeal Carcinoma: A Dose-Volume Analysis. J Cancer. 2016 Jan 8;7(3):276-82. doi: 10.7150/jca.13183. eCollection 2016.
PubMed 26918040Diao K, Nguyen TP, Moreno AC, Reddy JP, Garden AS, Wang CH, Tung S, Wang C, Wang XA, Rosenthal DI, Fuller CD, Gunn GB, Frank SJ, Morrison WH, Shah SJ, Lee A, Spiotto MT, Su SY, Ferrarotto R, Phan J. Stereotactic body ablative radiotherapy for reirradiation of small volume head and neck cancers is associated with prolonged survival: Large, single-institution, modern cohort study. Head Neck. 2021 Nov;43(11):3331-3344. doi: 10.1002/hed.26820. Epub 2021 Jul 16.
PubMed 34269492Grimm J, Vargo JA, Mavroidis P, Moiseenko V, Emami B, Jain S, Caudell JJ, Clump DA, Ling DC, Das S, Moros EG, Vinogradskiy Y, Xue J, Heron DE. Initial Data Pooling for Radiation Dose-Volume Tolerance for Carotid Artery Blowout and Other Bleeding Events in Hypofractionated Head and Neck Retreatments. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):147-159. doi: 10.1016/j.ijrobp.2020.12.037. Epub 2021 Feb 11.
PubMed 33583641Hanna GG, Murray L, Patel R, Jain S, Aitken KL, Franks KN, van As N, Tree A, Hatfield P, Harrow S, McDonald F, Ahmed M, Saran FH, Webster GJ, Khoo V, Landau D, Eaton DJ, Hawkins MA. UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. Clin Oncol (R Coll Radiol). 2018 Jan;30(1):5-14. doi: 10.1016/j.clon.2017.09.007. Epub 2017 Oct 13.
PubMed 29033164Ng SP, Wang H, Pollard C 3rd, Nguyen T, Bahig H, Fuller CD, Gunn GB, Garden AS, Reddy JP, Morrison WH, Shah S, Rosenthal DI, Frank SJ, Guha-Thakurta N, Ferrarotto R, Hanna EY, Su SY, Phan J. Patient Outcomes after Reirradiation of Small Skull Base Tumors using Stereotactic Body Radiotherapy, Intensity Modulated Radiotherapy, or Proton Therapy. J Neurol Surg B Skull Base. 2020 Dec;81(6):638-644. doi: 10.1055/s-0039-1694052. Epub 2019 Jul 31.
PubMed 33381367Gerhard SG, Palma DA, Arifin AJ, Louie AV, Li GJ, Al-Shafa F, Cheung P, Rodrigues GB, Bassim CW, Corkum MT. Organ at Risk Dose Constraints in SABR: A Systematic Review of Active Clinical Trials. Pract Radiat Oncol. 2021 Jul-Aug;11(4):e355-e365. doi: 10.1016/j.prro.2021.03.005.
PubMed 34217495Nichols AC, Lang P, Prisman E, Berthelet E, Tran E, Hamilton S, Wu J, Fung K, de Almeida JR, Bayley A, Goldstein DP, Eskander A, Husain Z, Bahig H, Christopoulous A, Hier M, Sultanem K, Richardson K, Mlynarek A, Krishnan S, Le H, Yoo J, MacNeil SD, Mendez A, Winquist E, Read N, Venkatesan V, Kuruvilla S, Warner A, Mitchell S, Corsten M, Rajaraman M, Johnson-Obaseki S, Eapen L, Odell M, Chandarana S, Banerjee R, Dort J, Matthews TW, Hart R, Kerr P, Dowthwaite S, Gupta M, Zhang H, Wright J, Parker C, Wehrli B, Kwan K, Theurer J, Palma DA. Treatment de-escalation for HPV-associated oropharyngeal squamous cell carcinoma with radiotherapy vs. trans-oral surgery (ORATOR2): study protocol for a randomized phase II trial. BMC Cancer. 2020 Feb 14;20(1):125. doi: 10.1186/s12885-020-6607-z.
PubMed 32059705Nichols AC, Yoo J, Hammond JA, Fung K, Winquist E, Read N, Venkatesan V, MacNeil SD, Ernst DS, Kuruvilla S, Chen J, Corsten M, Odell M, Eapen L, Theurer J, Doyle PC, Wehrli B, Kwan K, Palma DA. Early-stage squamous cell carcinoma of the oropharynx: radiotherapy vs. trans-oral robotic surgery (ORATOR)--study protocol for a randomized phase II trial. BMC Cancer. 2013 Mar 20;13:133. doi: 10.1186/1471-2407-13-133.
PubMed 23514246
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07337161
- Acronym / sponsor ID
- SPRINT / 5201
- Keywords
- skin, head and neck, radiation, SBRT, SABR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- David PalmaUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2035 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control | Active comparator | Radiation: Standard RadiationPatients 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 |
| Arm 2: SBRT arm | Experimental | Radiation: SBRTPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTPatients 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 | Arm 2: SBRT arm |
| Standard RadiationPatients 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 | Arm 1: Control |
Primary outcome
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
7 secondary outcomes
Regional recurrence
Time frame: 2 years
Disease-free survival (DFS)
Time frame: 2 years
Overall survival
Time frame: 2 years
Rate of salvage surgery
Time frame: 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.
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 Outcome
Time frame: Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- BackgroundCulbert M, Bidermann G, Wallace AS. Decisional preferences and satisfaction with short-course radiation for breast cancer. JCO. 2018;36(30_suppl):193-193. doi:10.1200/JCO.2018.36.30_suppl.193
- BackgroundNational Comprehensive Cancer Network Squamous Cell Skin Cancer (version 1.2024). https://www.nccn.org/professionals/physician_gls/pdf/squamous.pdf. Accessed 24 August 2024.
- BackgroundNational Cancer Institute-Common Toxicity Criteria Adverse Events Version 5. Published 2017. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Refer ence_8.5x11.pdf. Accessed 25 August 2024.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 32957804Hatswell A, Freemantle N, Baio G, Lesaffre E, van Rosmalen J. Summarising salient information on historical controls: A structured assessment of validity and comparability across studies. Clin Trials. 2020 Dec;17(6):607-616. doi: 10.1177/1740774520944855. Epub 2020 Sep 21.
- Background: PubMed 770493Pocock SJ. The combination of randomized and historical controls in clinical trials. J Chronic Dis. 1976 Mar;29(3):175-88. doi: 10.1016/0021-9681(76)90044-8. No abstract available.
- Background: PubMed 17546575Ringash J, O'Sullivan B, Bezjak A, Redelmeier DA. Interpreting clinically significant changes in patient-reported outcomes. Cancer. 2007 Jul 1;110(1):196-202. doi: 10.1002/cncr.22799.
- Background: PubMed 26918040Yao JJ, Zhou GQ, Jin YN, Zhang WJ, Lin L, Yu XL, Shao JY, Ma J, Sun Y. Predictors of Mastoiditis after Intensity-Modulated Radiotherapy in Nasopharyngeal Carcinoma: A Dose-Volume Analysis. J Cancer. 2016 Jan 8;7(3):276-82. doi: 10.7150/jca.13183. eCollection 2016.
- Background: PubMed 34269492Diao K, Nguyen TP, Moreno AC, Reddy JP, Garden AS, Wang CH, Tung S, Wang C, Wang XA, Rosenthal DI, Fuller CD, Gunn GB, Frank SJ, Morrison WH, Shah SJ, Lee A, Spiotto MT, Su SY, Ferrarotto R, Phan J. Stereotactic body ablative radiotherapy for reirradiation of small volume head and neck cancers is associated with prolonged survival: Large, single-institution, modern cohort study. Head Neck. 2021 Nov;43(11):3331-3344. doi: 10.1002/hed.26820. Epub 2021 Jul 16.
- Background: PubMed 33583641Grimm J, Vargo JA, Mavroidis P, Moiseenko V, Emami B, Jain S, Caudell JJ, Clump DA, Ling DC, Das S, Moros EG, Vinogradskiy Y, Xue J, Heron DE. Initial Data Pooling for Radiation Dose-Volume Tolerance for Carotid Artery Blowout and Other Bleeding Events in Hypofractionated Head and Neck Retreatments. Int J Radiat Oncol Biol Phys. 2021 May 1;110(1):147-159. doi: 10.1016/j.ijrobp.2020.12.037. Epub 2021 Feb 11.
- Background: PubMed 29033164Hanna GG, Murray L, Patel R, Jain S, Aitken KL, Franks KN, van As N, Tree A, Hatfield P, Harrow S, McDonald F, Ahmed M, Saran FH, Webster GJ, Khoo V, Landau D, Eaton DJ, Hawkins MA. UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy. Clin Oncol (R Coll Radiol). 2018 Jan;30(1):5-14. doi: 10.1016/j.clon.2017.09.007. Epub 2017 Oct 13.
- Background: PubMed 33381367Ng SP, Wang H, Pollard C 3rd, Nguyen T, Bahig H, Fuller CD, Gunn GB, Garden AS, Reddy JP, Morrison WH, Shah S, Rosenthal DI, Frank SJ, Guha-Thakurta N, Ferrarotto R, Hanna EY, Su SY, Phan J. Patient Outcomes after Reirradiation of Small Skull Base Tumors using Stereotactic Body Radiotherapy, Intensity Modulated Radiotherapy, or Proton Therapy. J Neurol Surg B Skull Base. 2020 Dec;81(6):638-644. doi: 10.1055/s-0039-1694052. Epub 2019 Jul 31.
- Individual participant dataSharing planned: Undecided
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Hip Disease, Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT and Standard Radiation in people with Cutaneous and Head and Neck Cancer Squamous Cell Carcinoma, run by David Palma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Palma (519-685-8500, david.palma@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07337161, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.