The purpose of this study is to test the hypothesis that 1)intensity-modulated radiotherapy
(IMRT) or proton radiation therapy would result in improved local control rate and lowered
toxicity compared to conventional radiotherapy, and 2) proton radiation therapy would result
in equivalent or improved local control rate with similar or lower toxicity compared to IMRT,
in the treatment of locally advanced sinonasal malignancy.
Data from retrospective studies suggest that IMRT or proton radiation therapy resulted in
promising outcome in patients with sinonasal malignancy. To this date, no prospective study
has been conducted to evaluate the outcome of sinonasal cancer treated with IMRT or proton
radiation therapy. This Phase II trial is the first prospective study conducted to determine
the treatment outcome and toxicity of IMRT or proton in the treatment of sinonasal cancer.
IMRT and proton radiation therapy are the two most established and most commonly employed
advanced radiotherapy techniques for the treatment of sinonasal cancer. It is highly
controversial whether one is superior to the other in terms of local control and toxicity
outcome. It is also not clear if a subset of patients would benefit more from one treatment
technology versus the other.
Due to the rarity and heterogeneity of sinonasal malignancies and the fact that proton beam
is only available at a few centers in the United States, it is not feasible at present to do
a Phase III study randomizing patients between IMRT and proton radiation therapy. In this
study, a planned secondary analysis will be performed, comparing the treatment and toxicity
outcome between IMRT and proton. The data on the IMRT and proton comparison from this trial
will be used to design future multi-center prospective trials and to determine if randomized
trial is necessary.
In this study, the treatment technique employed for an individual case will not be determined
by the treating physician(s), but rather by the most advanced technology available at the
treating institution for the treatment of the sinonasal cancer. At the Massachusetts General
Hospital (MGH), proton beam therapy will be used for patients who meet the eligibility
criteria. For institutions where protons are not available or institutions where the proton
planning systems have not been optimized, IMRT exclusively will be used for the treatment of
sinonasal cancer. Patient and tumor characteristics are expected to be comparable between
IMRT- and proton- institutions