NCT00255814

Radiation Therapy in Treating Patients With Liver Metastases

A Phase I Trial of Highly Conformal Radiation Therapy for Patients With Liver Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Specialized 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. PURPOSE: This phase I trial is studying the side effects and best dose of radiation therapy in treating patients with liver metastases.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose of high dose per fraction, highly conformal radiotherapy in patients with liver metastases. Secondary * Determine the failure patterns and survival of patients treated with this regimen. * Correlate dose-volume characteristics with possible toxic effects of this regimen in these patients. * Determine the local control rate within irradiated fields in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study. Patients undergo highly conformal radiotherapy (HCR) to the liver once daily, 5 days a week, for 2 weeks. Cohorts of 6 patients receive escalating doses of HCR until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Conditions

• Metastatic Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy

Timeline

• Start date: 2005-11-01
• Primary completion: 2011-09-01
• Completion: 2013-11-01
• First posted: 2005-11-21
• Last updated: 2015-11-17

Locations

3 sites across 2 countries: United States, Canada