Hypofractionated Radiation for Preoperative Treatment of Patients with Sarcoma

PRIMARY OBJCETIVE:

I. In patients undergoing preoperative radiotherapy for extremity or trunk soft tissue sarcoma, compare the major wound complication rate in patients treated with neoadjuvant chemotherapy versus patients receiving neoadjuvant radiotherapy alone.

SECONDARY OBJECTIVES:

I. Evaluate the 2 year rate of grade >= 2 radiation morbidity (subcutaneous fibrosis, joint stiffness, or edema) with a 5 fraction radiation regimen that is biologically equivalent to a standard 45-50 Gy regimen given in 25 fractions.

II. Evaluate local control, regional control, distant metastasis, progression free survival, and overall survival.

III. Evaluate the functional outcomes as assessed using the musculoskeletal tumor rating scale (MSTS) and the Toronto Extremity Salvage Score (TESS).

EXPLORATORY OBJECTIVES:

I. Investigate the association of germ-line mutations that impact cancer predisposition.

II. Investigate the role of germ-line mutations in predicting cancer outcome, toxicity and response to therapy.

III. Evaluate pre-treatment, post-radiotherapy and, if applicable, metastatic or relapse tissue specimens for characteristics including DNA alterations, gene expression, protein expression, immunophenotype and intratumoral heterogeneity that may be predictive, prognostic or explain resistance.

OUTLINE: Patients undergo hypofractionated radiation therapy for 5 consecutive weekdays. Beginning 2-12 weeks after completion of radiation therapy, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months and then every 6 months for 5 years.