Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
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|ClinicalTrials.gov Identifier: NCT00938457|
Recruitment Status : Terminated (poor accrual)
First Posted : July 13, 2009
Results First Posted : July 9, 2012
Last Update Posted : May 19, 2016
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor||Radiation: stereotactic radiation therapy Procedure: implanted fiducial-based imaging Procedure: cone-beam computed tomography||Phase 1 Phase 2|
OUTLINE: This is a phase I/II, dose-escalation study.
Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||April 2011|
Experimental: Arm I
Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Radiation: stereotactic radiation therapy
Patients undergo stereotactic body radiation therapyProcedure: implanted fiducial-based imaging
radiation therapy treatment planningProcedure: cone-beam computed tomography
radiation therapy treatment planning
- Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases. [ Time Frame: 2 months ]
- Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II) [ Time Frame: At 1 year ]LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.
- Toxicity and Adverse Events Profile (Phase I) [ Time Frame: Up to 2 years ]
Number of patients with a grade >= 3 adverse event.
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
- Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I) [ Time Frame: Up to 2 years ]
- Radiographic Response Rate (Phase II) [ Time Frame: Up to 2 years ]
- Local Control (LC) Cumulative Incidence Rates (Phase II) [ Time Frame: 3 and 6 months and 1, 2, and 5 years ]
- Median Time to Progression of Treated Tumors (Phase II) [ Time Frame: Up to 5 years ]
- Refinement of Toxicity and Adverse Events Profile (Phase II) [ Time Frame: Up to 2 years ]
- Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II) [ Time Frame: Up to 2 years ]
- Evaluation of Cause of Death (Phase II) [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938457
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Robert C. Miller, M.D.||Mayo Clinic|