Carcinoma of the Head and Neck Clinical Trial
Official title:
A Phase II Protocol of Intensity-Modulated Radiotherapy for Treatment of Previously Irradiated Recurrent Head and Neck Cancer
To demonstrate safety and efficacy of intensity-modulated radiotherapy (IMRT) for treatment
of previously irradiated recurrent head and neck cancer.
Specific Aims: Identify acute and late toxicities, response rates, locoregional control,
disease free survival, and overall survival with IMRT. Also, tumor response, the amount of
tumor shrinkage or reduction, will be analyzed.
Rationale: Recurrent head and neck cancer is regarded as having limited treatment modalities
since salvage surgery can only be accomplished on limited subgroups of patients. Chemotherapy
has not shown clear clinical benefits and has significant toxicity. Re-irradiation has been
used as a treatment modality. However, the re-irradiation dose is limited by significant
toxicity that occurs with the cumulative dose of radiation. The use of IMRT can give a high
dose to the recurrent tumor while limiting the dose to critical structures in the vicinity of
the reirradiated volume thereby limiting toxicity and treating the recurrence to an adequate
dose.
The number of subjects was determined from 2 stage design with a historical control group as
comparison, and these numbers of subjects were found to be 40.
It is assumed that this treatment regimen will not be of further interest if the true
response rate is less than 32.6% (Po0.326). It is also assumed that a true response rate of
53% or more (P10.53) would be of considerable interest in the treatment of recurrent head and
neck cancer. The type I error (the probability of rejecting the hypothesis that the
proportion responding to the treatment is less than or equal to Po when this hypothesis is
actually true) is 0.05.
n/a
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