Sarcoma Clinical Trial
Official title:
Phase II Study of Preoperative Intensity-Modulated Radiation Therapy for Soft-Tissue Sarcomas
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation
therapy before surgery may make the tumor smaller and reduce the amount of normal tissue
that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation
therapy and to see how well it works in treating patients undergoing surgery for stage IB,
stage II, or stage III soft tissue sarcoma.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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