Clinical trial · Interventional
Stereotactic Post-operative Radiotherapy for Intraparotid Metastatic Cutaneous Squamous Cell Carcinoma
NCT07337161CI-TRIAL-00100699SPRINTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous | — | UNRESOLVED | — |
| Head and Neck Cancer Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
| Standard Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1: Control
- description
- 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
- interventionNames
- Radiation: Standard Radiation
- type
- EXPERIMENTAL
- label
- Arm 2: SBRT arm
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (38)
- 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.
- BACKGROUNDHarris 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. PMID 18929686
- BACKGROUNDHatswell 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. PMID 32957804
- BACKGROUNDPocock 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. PMID 770493
- BACKGROUNDRingash 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. PMID 17546575
- BACKGROUNDYao 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.