Status:
UNKNOWN
A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Juravinski Cancer Centre Foundation
Conditions:
Head and Neck Neoplasms
Squamous Cell Carcinoma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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 tre...
Detailed Description
Cancers of the head and neck region account for approximately 4% of all new cancer cases. Primary skin cancers are the most common malignancy diagnosed in North America with the majority of tumours ar...
Eligibility Criteria
Inclusion
- Age \>= 60 years
- 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)
- Clinical stage ≥ T2, or any T-stage with N1-N3 disease, M0 or Mx
- Measurable tumour present in the head and neck region on clinical examination and/or imaging at time of study enrollment
- 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
- 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
- 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
- Eastern Co-operative Oncology Group (ECOG) Performance Status ≤ 3
Exclusion
- Life expectancy ≤ 3 months
- Chemotherapy or other systemic cancer therapy within 3 months prior to HN SBRT
- Basal cell carcinoma, Merkel cell, malignant melanoma, adenocarcinoma are excluded
- HN surgery within 6 months prior to HN SBRT (excision under local anaesthesia is acceptable)
- 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)
- 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)
- Confirmed or known distant metastatic disease.
- Serious non-malignant disease that precludes definitive radiation treatment (e.g.
- severe cases of scleroderma, systemic lupus erythematosus, rheumatoid arthritis)
- Unable to provide written, informed consent or complete QoL questionnaires and assessments required on the study
- Unable to lie flat for 60 minutes in order to have radiation planning and treatment
- Unable to attend radiation planning and therapy, as well as follow-up care and assessments
- Unable to provide written, informed consent
Key Trial Info
Start Date :
September 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04435938
Start Date
September 10 2020
End Date
December 1 2022
Last Update
December 2 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2