Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma
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.
Adult Soft Tissue Sarcoma
Radiation: Proton Beam Radiation Therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Proton Radiotherapy for Retroperitoneal Sarcoma|
- Feasibility [ Designated as safety issue: No ]
- Acute toxicity as assessed by NCI CTC Version 3.0 [ Time Frame: Within 60 days of completion of radiotherapy ] [ Designated as safety issue: Yes ]
- Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system [ Time Frame: After 60 days of therapy ] [ Designated as safety issue: Yes ]
- Clinical efficacy (local recurrence-free survival, distant metastasis-free survival, and overall survival [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients undergo proton beam radiotherapy 5 days a week for 6 (preoperative patients) or 8 (post-operative patients) weeks in the absence of disease progression or unacceptable toxicity.
|Radiation: Proton Beam Radiation Therapy|
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)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034566
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|