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

Radiation Therapy Oncology Group3 sites in 2 countries26 target enrollmentNovember 2005

ConditionsMetastatic Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Cancer
Sponsor: Radiation Therapy Oncology Group
Enrollment: 26
Locations: 3
Primary Endpoint: To determine the maximally tolerated dose
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

November 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group