Clinical trial · Interventional
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases
NCT00938457CI-TRIAL-00022287terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cone-beam computed tomography | Procedure | — | UNRESOLVED |
| implanted fiducial-based imaging | Procedure | — | UNRESOLVED |
| stereotactic radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Radiation: stereotactic radiation therapy
- Procedure: implanted fiducial-based imaging
- Procedure: cone-beam computed tomography
Primary outcomes (2)
- measure
- Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
- timeFrame
- 2 months
- measure
- 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)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * 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 (Model for End-Stage Liver Disease) 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.