The goal of this study is to evaluate the effects of temozolomide and radiation combination in the treatment intended of soft tissue sarcomas. This study will also look at the tumor tissue that was removed during your initial biopsy and your final surgery for information that may help to treat soft tissue sarcoma in the future. In addition the investigators will examine a sample of your normal tissue (optional) from the inside of your mouth/cheek (to compare it to your tumor tissue) before starting treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks.Temozolomide: 75 mg/m2 five days per week during radiotherapy for 5 weeks. Temozolomide should be taken orally 1 hour before each session of radiotherapy during weekdays (Monday through Friday). The dose will be determined using the body surface area (BSA) calculated at the beginning of the concurrent treatment. The BSA will be calculated from the height obtained at the pretreatment visit and the weight obtained before the first day of treatment. The concurrent treatment will last until the end of radiotherapy.
50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)
Assess treatment feasibility of neoadjuvant temozolomide-based proton chemoradiotherapy for high-risk soft tissue sarcoma
Time frame: 6 months after surgery then every 6 months for 3 years
Evaluate acute and late toxicities
Time frame: Weekly during treatment, 6 months after surgery, then every 6 months for 3 years
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Proton Chemoradiotherapy followed by surgery. Resection of tumor at 4-6 weeks post-treatment.