Head and Neck Cancers Clinical Trial
Official title:
StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Patients Receiving Concurrent Chemoradiation for Head and Neck Cancers
Clinical significance and current evidence:
Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal
cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant
morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment.
Current literature does not conclusively support the use of one agent over another for
prevention of radiation dermatitis. The choice of agents used in clinical practice is highly
variable, with aqueous agents being one of the commonest.
Specific Aims:
The aim of this study is to evaluate if the investigational product (StrataXRT), a
silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or
higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma.
Trial Design:
The study will be conducted using a prospective, double-blind randomized control trial in 2
institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with
concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and
the primary endpoint is reached when grade 2 or higher dermatitis according to the Common
Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary
objectives will be evaluation of the time to onset of dermatitis, the time to complete
recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be
done at baseline, weekly during treatment, 1 week post treatment and unless the skin has
resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end
of follow-up. The safety end-point is reached when grade 4 dermatitis occurs.
Hypothesis and statistics:
The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher
dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the
difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients
in total. The study duration is estimated to be 2 years.
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