Spots Global Cancer Trial Database for Stereotactic Radiosurgery for Patients With Hepatic Metastases.

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Trial Identification

Brief Title: Stereotactic Radiosurgery for Patients With Hepatic Metastases.

Official Title: A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)

Study ID: NCT00547677

Conditions

Metastatic Cancer

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

stereotactic radiosurgery

Study Description

Brief Summary: RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.

Detailed Description: OBJECTIVES: * To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in patients with hepatic metastases. * To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients. * To assess the tumor response in these patients. OUTLINE: This is a multicenter study. Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which \> 33% of patients experience dose-limiting toxicity. After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.