Radiation Therapy in Treating Patients With Liver Metastases
- Conditions
- Metastatic Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00255814
- Lead Sponsor
- Radiation Therapy Oncology Group
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiation therapy dose level III: 4.5 Gy/fx radiation therapy Radiation therapy dose level III: 4.5 Gy/fraction Radiation therapy dose level II: 4.0 Gy/fx radiation therapy Radiation therapy dose level II: 4.0 Gy/fraction Radiation therapy dose level IV: 5.0 Gy/fx radiation therapy Radiation therapy dose level IV: 5.0 Gy/fraction
- Primary Outcome Measures
Name Time Method To determine the maximally tolerated dose From start of treatment to 90 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada