Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 15521 | Other Identifier | London Health Science Centre (LHSCRI) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Patients will receive ultra-hypofractionated stereotactic radiation over 5 treatments delivered every other weekday or twice weekly as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Regional recurrence | calculated as time from randomization to evidence of disease recurrence anywhere in the ipsilateral parotid gland or neck | 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. |
Not provided
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:
Neoadjuvant or adjuvant immunotherapy is allowed
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Palma | Contact | 519-685-8500 | david.palma@lhsc.on.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verspeeten Family Cancer Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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. | ||
| Background | 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. | ||
| 18929686 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Radiation | 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 |
|
| 2 years |
| Overall survival | calculated as time from randomization to death from any cause, or last follow-up, whichever occurs first. | 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. | 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. | 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. | 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. | Baseline, 3, 6, 12, 18, 24 months post-treatment and yearly from years 2-5 after the end of radiation. |
| 32957804 | Background | Hatswell 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. |
| 770493 | Background | Pocock 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. |
| 17546575 | Background | Ringash 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. |
| 26918040 | Background | Yao 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. |
| 34269492 | Background | Diao 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. |
| 33583641 | Background | Grimm 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. |
| 29033164 | Background | Hanna 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. |
| 33381367 | Background | Ng 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. |
| 34217495 | Background | Gerhard 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. |
| 32059705 | Background | Nichols 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. |
| 23514246 | Background | Nichols 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. |
| 27930762 | Background | Siu LL, Waldron JN, Chen BE, Winquist E, Wright JR, Nabid A, Hay JH, Ringash J, Liu G, Johnson A, Shenouda G, Chasen M, Pearce A, Butler JB, Breen S, Chen EX, FitzGerald TJ, Childs TJ, Montenegro A, O'Sullivan B, Parulekar WR. Effect of Standard Radiotherapy With Cisplatin vs Accelerated Radiotherapy With Panitumumab in Locoregionally Advanced Squamous Cell Head and Neck Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):220-226. doi: 10.1001/jamaoncol.2016.4510. |
| Background | A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer. Published online August 8, 2009. Accessed August 15, 2024. https://clinicaltrials.gov/study/NCT00956007 |
| 30449625 | Background | Gillison ML, Trotti AM, Harris J, Eisbruch A, Harari PM, Adelstein DJ, Jordan RCK, Zhao W, Sturgis EM, Burtness B, Ridge JA, Ringash J, Galvin J, Yao M, Koyfman SA, Blakaj DM, Razaq MA, Colevas AD, Beitler JJ, Jones CU, Dunlap NE, Seaward SA, Spencer S, Galloway TJ, Phan J, Dignam JJ, Le QT. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. 2019 Jan 5;393(10166):40-50. doi: 10.1016/S0140-6736(18)32779-X. Epub 2018 Nov 15. |
| 36790039 | Background | Hu M, Kim ANH, Emeto TI, Collins M, Chopping A, Lin C. Metastatic cutaneous squamous cell carcinoma to the parotid: Adjuvant radiotherapy and treatment outcomes. J Med Radiat Sci. 2023 Jun;70(2):161-170. doi: 10.1002/jmrs.650. Epub 2023 Feb 15. |
| 16114004 | Background | Hong TS, Kriesel KJ, Hartig GK, Harari PM. Parotid area lymph node metastases from cutaneous squamous cell carcinoma: implications for diagnosis, treatment, and prognosis. Head Neck. 2005 Oct;27(10):851-6. doi: 10.1002/hed.20256. |
| 28677515 | Background | Coombs AC, Butler A, Allison R. Metastatic cutaneous squamous cell carcinoma of the parotid gland: prognostic factors. J Laryngol Otol. 2018 Mar;132(3):264-269. doi: 10.1017/S0022215117001323. Epub 2017 Jul 5. |
| 17689882 | Background | Chen AM, Grekin RC, Garcia J, Bucci MK, Margolis LW. Radiation therapy for cutaneous squamous cell carcinoma involving the parotid area lymph nodes: dose and volume considerations. Int J Radiat Oncol Biol Phys. 2007 Dec 1;69(5):1377-80. doi: 10.1016/j.ijrobp.2007.05.005. Epub 2007 Aug 8. |
| 34648871 | Background | Voruganti IS, Poon I, Husain ZA, Bayley A, Barnes EA, Zhang L, Chin L, Erler D, Higgins K, Enepekides D, Eskander A, Karam I. Stereotactic body radiotherapy for head and neck skin cancer. Radiother Oncol. 2021 Dec;165:1-7. doi: 10.1016/j.radonc.2021.10.004. Epub 2021 Oct 11. |
| 32758188 | Background | Biau J, Thivat E, Millardet C, Saroul N, Pham-Dang N, Molnar I, Pereira B, Durando X, Bourhis J, Lapeyre M. A multicenter prospective phase II study of postoperative hypofractionated stereotactic body radiotherapy (SBRT) in the treatment of early-stage oropharyngeal and oral cavity cancers with high risk margins: the STEREO POSTOP GORTEC 2017-03 trial. BMC Cancer. 2020 Aug 5;20(1):730. doi: 10.1186/s12885-020-07231-3. |
| 37894377 | Background | Mohamad I, Karam I, El-Sehemy A, Abu-Gheida I, Al-Ibraheem A, Al-Assaf H, Aldehaim M, Alghamdi M, Alotain I, Ashour M, Bushehri A, ElHaddad M, Hosni A. The Evolving Role of Stereotactic Body Radiation Therapy for Head and Neck Cancer: Where Do We Stand? Cancers (Basel). 2023 Oct 16;15(20):5010. doi: 10.3390/cancers15205010. |
| 32580883 | Background | Murray Brunt A, Haviland JS, Wheatley DA, Sydenham MA, Alhasso A, Bloomfield DJ, Chan C, Churn M, Cleator S, Coles CE, Goodman A, Harnett A, Hopwood P, Kirby AM, Kirwan CC, Morris C, Nabi Z, Sawyer E, Somaiah N, Stones L, Syndikus I, Bliss JM, Yarnold JR; FAST-Forward Trial Management Group. Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial. Lancet. 2020 May 23;395(10237):1613-1626. doi: 10.1016/S0140-6736(20)30932-6. Epub 2020 Apr 28. |
| 30977859 | Background | Raldow AC, Chen AB, Russell M, Lee PP, Hong TS, Ryan DP, Cusack JC, Wo JY. Cost-effectiveness of Short-Course Radiation Therapy vs Long-Course Chemoradiation for Locally Advanced Rectal Cancer. JAMA Netw Open. 2019 Apr 5;2(4):e192249. doi: 10.1001/jamanetworkopen.2019.2249. |
| 34096664 | Background | Newman JG, Hall MA, Kurley SJ, Cook RW, Farberg AS, Geiger JL, Koyfman SA. Adjuvant therapy for high-risk cutaneous squamous cell carcinoma: 10-year review. Head Neck. 2021 Sep;43(9):2822-2843. doi: 10.1002/hed.26767. Epub 2021 Jun 7. |
| 35042657 | Background | Melo GM, Guilherme LH, Palumbo MDN, Rosano M, Neves MCD, Callegari FM, Abrahao M, Cervantes O. Parotidectomy and neck dissection in locally advanced and relapsed cutaneous squamous cell carcinoma of the head and neck region. Braz J Otorhinolaryngol. 2022 Nov-Dec;88 Suppl 4(Suppl 4):S152-S162. doi: 10.1016/j.bjorl.2021.11.007. Epub 2021 Dec 10. |
| 14520114 | Background | Veness MJ, Palme CE, Smith M, Cakir B, Morgan GJ, Kalnins I. Cutaneous head and neck squamous cell carcinoma metastatic to cervical lymph nodes (nonparotid): a better outcome with surgery and adjuvant radiotherapy. Laryngoscope. 2003 Oct;113(10):1827-33. doi: 10.1097/00005537-200310000-00031. |
| 12001070 | Background | O'Brien CJ, McNeil EB, McMahon JD, Pathak I, Lauer CS, Jackson MA. Significance of clinical stage, extent of surgery, and pathologic findings in metastatic cutaneous squamous carcinoma of the parotid gland. Head Neck. 2002 May;24(5):417-22. doi: 10.1002/hed.10063. |
| 11505484 | Background | O'Brien CJ, McNeil EB, McMahon JD, Pathak I, Lauer CS. Incidence of cervical node involvement in metastatic cutaneous malignancy involving the parotid gland. Head Neck. 2001 Sep;23(9):744-8. doi: 10.1002/hed.1106. |
| 18849863 | Background | Hinerman RW, Indelicato DJ, Amdur RJ, Morris CG, Werning JW, Vaysberg M, Kirwan J, Mendenhall WM. Cutaneous squamous cell carcinoma metastatic to parotid-area lymph nodes. Laryngoscope. 2008 Nov;118(11):1989-96. doi: 10.1097/MLG.0b013e318180642b. |
| 24722863 | Background | Thom JJ, Moore EJ, Price DL, Kasperbauer JL, Starkman SJ, Olsen KD. The Role of Total Parotidectomy for Metastatic Cutaneous Squamous Cell Carcinoma and Malignant Melanoma. JAMA Otolaryngol Head Neck Surg. 2014 Jun;140(6):548-54. doi: 10.1001/jamaoto.2014.352. |
| 24183870 | Background | Gregoire V, Ang K, Budach W, Grau C, Hamoir M, Langendijk JA, Lee A, Le QT, Maingon P, Nutting C, O'Sullivan B, Porceddu SV, Lengele B. Delineation of the neck node levels for head and neck tumors: a 2013 update. DAHANCA, EORTC, HKNPCSG, NCIC CTG, NCRI, RTOG, TROG consensus guidelines. Radiother Oncol. 2014 Jan;110(1):172-81. doi: 10.1016/j.radonc.2013.10.010. Epub 2013 Oct 31. |
| 35255046 | Background | Bradley PJ. Parotid lymph nodes in primary malignant salivary neoplasms. Curr Opin Otolaryngol Head Neck Surg. 2022 Apr 1;30(2):99-106. doi: 10.1097/MOO.0000000000000772. |
| 31831330 | Background | Likhacheva A, Awan M, Barker CA, Bhatnagar A, Bradfield L, Brady MS, Buzurovic I, Geiger JL, Parvathaneni U, Zaky S, Devlin PM. Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: Executive Summary of an American Society for Radiation Oncology Clinical Practice Guideline. Pract Radiat Oncol. 2020 Jan-Feb;10(1):8-20. doi: 10.1016/j.prro.2019.10.014. Epub 2019 Dec 9. |
| 38099564 | Background | Eggermont CJ, Eggermont AMM. Shifting landscape in skin cancer incidence: the rising tide of cutaneous squamous cell carcinoma and potential implications for prevention. Br J Dermatol. 2024 Mar 15;190(4):460-461. doi: 10.1093/bjd/ljad480. No abstract available. |