Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

Adult Soft Tissue Sarcoma Clinical Trial

Official title: Proton Radiotherapy for Retroperitoneal Sarcoma

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Adult Soft Tissue Sarcoma
• Sarcoma

• NCT number: NCT01034566
• Study type: Interventional
• Source: Abramson Cancer Center of the University of Pennsylvania
• Status: Withdrawn
• Phase: N/A
• Start date: November 2009
• Completion date: January 2013