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| Sponsored by: |
Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00938457 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor |
Radiation: stereotactic radiation therapy Procedure: implanted fiducial-based imaging Procedure: cone-beam computed tomography |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | November 2017 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
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 therapy
Procedure: implanted fiducial-based imaging
radiation therapy treatment planning
Procedure: cone-beam computed tomography
radiation therapy treatment planning
|
PRIMARY OBJECTIVES: I. Phase I (dose-escalation): Identify the maximum tolerated dose (MTD) of single-fraction stereotactic body radiation therapy (SF-SBRT) in hepatic metastases. II. Phase II (expanded cohorts): 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. SECONDARY OBJECTIVES: I. Phase I (dose-escalation): Determine the toxicity and adverse events profile. II. Phase I (dose-escalation): Examine patient clinical response and treatment effects on blood chemistry and hepatic function markers. III. Phase II (expanded cohorts): Determine the radiographic response rate. IV. Phase II (expanded cohorts): Identify the LC cumulative incidence rates at 3 and 6 months and 1, 2, and 5 years. V. Phase II (expanded cohorts): Determine the median time to progression of treated tumors. VI. Phase II (expanded cohorts): Refine the toxicity and adverse events profile. VII. Phase II (expanded cohorts): Refine the patient clinical response and treatment effects on blood chemistry and hepatic function markers. VIII. Phase II (expanded cohorts): Evaluate the cause of death. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy) One to three metastatic liver lesions =< 5 cm in dimension Intrahepatic cholangiocarcinoma is acceptable for inclusion Zubrod Performance Status (PS) 0 or 1 Please contact study investigator and/or consult protocol document for specific details on laboratory criteria Life expectancy >= 12 weeks MELD score =< 16 >= 1000 cc of uninvolved liver parenchyma as determined by the treating physician Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology Provide informed written consent Willingness to return to Mayo Clinic Rochester for follow-up Exclusion Pregnant women Nursing women Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible) Current diagnosis of hepatocellular carcinoma
Contacts and Locations More Information
| Responsible Party: | Mayo Clinic Rochester ( Macdonald, Orlan ) |
| Study ID Numbers: | NCI-2009-01150, MC0941 |
| Study First Received: | July 9, 2009 |
| Last Updated: | July 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00938457 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
protocol specific |
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Signs and Symptoms Neoplasm Metastasis |
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Neoplasms Neoplastic Processes Pathologic Processes Neoplasm Metastasis |
