Clinical trial · Interventional
A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
A Phase 2 Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
NCT04435938CI-TRIAL-00048600SHINEunknownPhase 2ClinicalTrials.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)
To evaluate the tumour response rate of squamous cell carcinoma of the head and neck following stereotactic body radiotherapy (SBRT) of 45Gy in 5 fractions delivered once every 3-4 days, such that treatment is completed within 15 days.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Skin Carcinoma | Squamous Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiotherapy (SBRT)
- description
- The dose prescribed in the study will be 45Gy in 5 fractions, delivered once every 3-4 days, such that treatment is completed within 15 days. (e.g. treatment given on Monday/Thursday/Mon/Thurs/Mon) (Exceptions: treatment duration of up to 18 days will be allowed to account for cancer centre closures and unforeseen patient issues.)
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Tumour response rate
- timeFrame
- The best overall response across all time points during the study period - up to 24 months after completion of SBRT.
- description
- Tumour response rate defined as complete or partial response according to Tumour response rate will be defined by RECIST 1.1 criteria
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 60 years 2. Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck region including primary skin SCC; (malignant cells with suspicious/likely SCC will be considered for study if repeat biopsy is not feasible) 3. Clinical stage ≥ T2, or any T-stage with N1-N3 disease, M0 or Mx 4. Measurable tumour present in the head and neck region on clinical examination and/or imaging at time of study enrollment 5. All patients will be assessed by a multi-disciplinary, head and neck oncology team with no systemic therapy being recommended at the time of enrollment 6. Primary surgery not recommended/performed due to any of the following: * Unresectable disease and/or borderline resectable * Medically inoperable / deemed high risk for post-operative morbidity/mortality by surgical team * Patient declined surgery 7. Deemed not to be a candidate for standard fractionation radiotherapy due to poor performance status and/or medical co-morbidities and/or advanced stage disease 8. Eastern Co-operative Oncology Group (ECOG) Performance Status ≤ 3 Exclusion Criteria: 1. Life expectancy ≤ 3 months 2. Chemotherapy or other systemic cancer therapy within 3 months prior to HN SBRT 3. Basal cell carcinoma, Merkel cell, malignant melanoma, adenocarcinoma are excluded 4. HN surgery within 6 months prior to HN SBRT (excision under local anaesthesia is acceptable) 5. Prior radiation treatment to the head and neck region (prior radiotherapy to the skin for non-melanoma skin cancer and deemed to have no risk of overlap with the current field are eligible) 6. Synchronous or recent cancer diagnosis not including the index cancer (other cancers treated curatively with no evidence of disease for \>=3 years, or other non- melanoma skin cancers treated with no evidence of disease for \>= 6 months are eligible) 7. Confirmed or known distant metastatic disease. 8. Serious non-malignant disease that precludes definitive radiation treatment (e.g. severe cases of scleroderma, systemic lupus erythematosus, rheumatoid arthritis) 9. Unable to provide written, informed consent or complete QoL questionnaires and assessments required on the study 10. Unable to lie flat for 60 minutes in order to have radiation planning and treatment 11. Unable to attend radiation planning and therapy, as well as follow-up care and assessments 12. Unable to provide written, informed consent
References
Publications (14)
- BACKGROUNDEskander A, Krzyzanowska MK, Fischer HD, Liu N, Austin PC, Irish JC, Enepekides DJ, Lee J, Gutierrez E, Lockhart E, Raphael M, Singh S. Emergency department visits and unplanned hospitalizations in the treatment period for head and neck cancer patients treated with curative intent: A population-based analysis. Oral Oncol. 2018 Aug;83:107-114. doi: 10.1016/j.oraloncology.2018.06.011. Epub 2018 Jun 19. PMID 30098764
- BACKGROUNDPignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14. PMID 19446902
- BACKGROUNDReid BC, Alberg AJ, Klassen AC, Samet JM, Rozier RG, Garcia I, Winn DM. Comorbidity and survival of elderly head and neck carcinoma patients. Cancer. 2001 Oct 15;92(8):2109-16. doi: 10.1002/1097-0142(20011015)92:83.0.co;2-m. PMID 11596027
- BACKGROUNDDatema FR, Ferrier MB, van der Schroeff MP, Baatenburg de Jong RJ. Impact of comorbidity on short-term mortality and overall survival of head and neck cancer patients. Head Neck. 2010 Jun;32(6):728-36. doi: 10.1002/hed.21245. PMID 19827120
- BACKGROUNDNguyen NT, Doerwald-Munoz L, Zhang H, Kim DH, Sagar S, Wright JR, Hodson DI. 0-7-21 hypofractionated palliative radiotherapy: an effective treatment for advanced head and neck cancers. Br J Radiol. 2015 May;88(1049):20140646. doi: 10.1259/bjr.20140646. Epub 2015 Feb 19. PMID 25694259
- BACKGROUNDCorry J, Peters LJ, Costa ID, Milner AD, Fawns H, Rischin D, Porceddu S. The 'QUAD SHOT'--a phase II study of palliative radiotherapy for incurable head and neck cancer. Radiother Oncol. 2005 Nov;77(2):137-42. doi: 10.1016/j.radonc.2005.10.008. Epub 2005 Nov 2. PMID 16260054
- Stevens CM, Huang SH, Fung S, Bayley AJ, Cho JB, Cummings BJ, Dawson LA, Hope AJ, Kim JJ, O'Sullivan B, Waldron JN, Ringash J. Retrospective study of palliative radiotherapy in newly diagnosed head and neck carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):958-63. doi: 10.1016/j.ijrobp.2010.06.055. Epub 2010 Oct 14.