NCT00881595

Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Soft Tissue Sarcomas

Interventions

Type	Name	Description
DRUG	Chemoradiotherapy Temozolomide	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.
RADIATION	Proton therapy	50 cobalt gray equivalent(CGE), 25 daily fractions, 5 weeks (2 CGE/fx)
PROCEDURE	Proton Chemoradiotherapy followed by surgery	Proton Chemoradiotherapy followed by surgery. Resection of tumor at 4-6 weeks post-treatment.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-04-15
• Last updated: 2017-02-10