Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma

Description

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) for P-SFRT, which will be used as the recommended phase II dose (RP2D) for P-SFRT prior to standard fractionated radiation therapy and surgical intervention for retroperitoneal sarcoma (RPS). (Phase I) II. To determine the efficacy of P-SFRT prior to standard fractionated radiation therapy and surgical intervention for RPS. (Phase II)

SECONDARY OBJECTIVES:

I. To determine whether P-SFRT is safe when administered prior to standard fractionated radiation therapy and surgery for RPS. (Phase I) II. To determine progression-free survival (PFS) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II) III. To determine overall survival (OS) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II) IV. To determine objective response (OR) in patients with RPS who have been treated with P-SFRT prior to standard fractionated radiation therapy and surgical intervention. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of P-SFRT followed by a phase II study.

Patients undergo P-SFRT over 1 fraction and then undergo image-guided intensity modulated radiation therapy (IG-IMRT) over 25-28 fractions for 35 to 42 days. Patients undergo surgical resection 21 to 35 days after radiation therapy. Patients undergo blood sample collection during screening and on study. Patients also undergo biopsy during screening and computed tomography (CT) on study and on follow up.

After completion of study treatment, patients are followed up at 30 and 90 days after surgery, and then up to 36 months.