RATIONALE: Specialized radiation therapy, such as proton beam 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 in patients with retroperitoneal sarcoma. PURPOSE: This phase I trial is studying the side effects and and best dose of proton beam radiation therapy in treating patients with retroperitoneal sarcoma.
Detailed DescriptionPRIMARY OBJECTIVES: I. To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas. II. To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas. III. To determine the maximally tolerated dose of proton radiotherapy for patients with potentially resectable retroperitoneal sarcoma. (Pre-operative cohort) IV. To assess acute side effects from irradiation using proton beam therapy and dose/volume constraints that are derived from conventional radiotherapy. (Postoperative cohort) SECONDARY OBJECTIVES: I. To assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma. II. To determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis region. III. To monitor for effects of proton treatment on tumor and normal tissues using radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (preoperative cohort only).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Acute toxicity as assessed by NCI CTC Version 3.0
Time frame: Within 60 days of completion of radiotherapy
Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system
Time frame: After 60 days of therapy
Clinical efficacy
Local recurrence-free survival, distant metastasis-free survival, and overall survival
Time frame: One year
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