Official Title
A Phase 2 Study of SBRT for Squamous Cell Carcinoma of the Head and Neck
Summary:
To evaluate the tumour response rate of squamous cell carcinoma of the head and neck
following stereotactic body radiation therapy (SBRT) of 45Gy in 5 fractions delivered once every
3-4 days, such that treatment is completed within 15 days.
Trial Description
Primary Outcome:
Secondary Outcome:
- Number of participants with Acute and Late Toxicity
- Local Control
- Quality of Life as measured by the FACT-HN questionnaire
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 arising in the cervico-facial region.Together, these tumours comprise a
high burden of illness and are often characterized by locally advanced, non-metastatic
disease.
Determining the optimal treatment for individual patients with advanced cervico-facial
cancers of the skin or primary head and neck squamous cell carcinoma (HNSCC) is clinically
challenging; standard treatments include combinations of surgery, radiation and chemotherapy,
all of which are associated with high rates of acute toxicity and complications. A
meta-analysis of randomized controlled trials did not demonstrate benefit with concurrent
chemotherapy in patients over the age of 70 or with performance status ≥ 2, and it is
recognized that the high burden of medical co-morbidities in HNSCC is associated with poorer
prognosis. Some patients without distant metastases may be deemed to have 'incurable' disease
due to very advanced tumours, recurrence, severe medical co-morbidities or frailty that
prohibit the use of standard surgery, general anaesthetic and/or radiation therapy over 6-7 weeks.
When conventional surgery and/or radiation therapy are not recommended by the multi-disciplinary
team then patients may be treated with shorter, hypo-fractionated radiation therapy with the goal
of symptom relief and local control but at the cost of a lower biological dose. Investigators
at the Juravinski Cancer Centre published retrospective results from the '0-7-21' regimen
using 24 Gy / 3 fractions which was well tolerated and provided temporary symptom relief in
82% of patients but reported 6 month progression free survival of 39% within the irradiated
field; a phase 2 study of previously untreated HNSCC patients deemed to have incurable
disease used up to 42 Gy/12 fractions and demonstrated similar rates of initial response and
symptom relief but a short progression free survival duration of 3.1 months. One study
reported an institutional experience of palliative radiation therapy in newly diagnosed head and
neck cancer patients who were deemed to have incurable disease and received a wide range of
dose/fractionation regimens. The median radiation dose was 50 Gy and between 57-82% of
patients were reported to have any radiological, clinical or symptomatic response to
treatment. In these three studies, the patients were older with median ages of 71, 73, and 77
years - and median survival was short 5.2, 5.7 and 6.2 months.
With respect to squamous cell carcinoma (SCC) of the skin, there is limited evidence to guide
treatment in patients with unresectable or medically inoperable disease, particularly in the
head and neck region. There is a need for prospective data on non-surgical treatment options
for frail older adults which improve efficacy while limiting the treatment burden.
SBRT can limit the number of treatments while delivering a higher, potentially curative dose.
An international consortium of 15 high volume cancer centres reported on a survey of
practices using SBRT for head and neck cancers. There was heterogeneity in the indications,
techniques and doses reported by various institutions. The most common indication was in the
setting of recurrent disease and reported doses were in the range of 35-50 Gy in 3-5
fractions. Several institutions reported 1-2 year local control rates of 65-90% with SBRT and
acceptable levels of toxicity. To our knowledge, there are no prospective clinical studies
evaluating tumour response, toxicity and quality of life in previously unirradiated patients.
The goal of the current study is to prospectively evaluate tumour response, toxicity and
patient quality of life in patients with HNSCC undergoing SBRT.
View this trial on ClinicalTrials.gov
