Trial Information

Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas

OBJECTIVES:

Primary

- Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma
(STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT).

Secondary

- Assess local control rate in patients treated with this regimen.

- Assess metastatic failure rate in patients treated with this regimen.

- Assess disease-free survival of patients treated with this regimen.

- Assess overall survival of patients treated with this regimen.

- Assess function and general health in these patients using the Musculoskeletal Tumor
Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36.

- Determine changes in STS gene expression after IMRT by microarray analyses.

- Correlate, preliminarily, changes in STS gene expression with pathological and clinical
outcomes.

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week
for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients then
undergo surgery > 1 month after completion of IMRT.

Tumor tissue samples are collected at baseline and at the time of surgery for correlative
laboratory studies. Samples are analyzed for gene expression by RNA microarray, real-time
polymerase chain reaction, and western blotting.

After completion of study treatment, patients are followed periodically for 2 years.