Proton Radiotherapy for 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).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility
No
United States: Institutional Review Board
UPCC 04509
NCT01034566
November 2009
November 2012
Name | Location |
---|---|
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |