Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

This study has been terminated.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00938457
First received: July 9, 2009
Last updated: June 4, 2012
Last verified: June 2012

July 9, 2009
June 4, 2012
July 2009
April 2011   (final data collection date for primary outcome measure)
  • Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    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.
Determination of the maximum tolerated dose (MTD) and the minimum effective dose (MED) [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00938457 on ClinicalTrials.gov Archive Site
  • Toxicity and Adverse Events Profile (Phase I) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
  • Radiographic Response Rate (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Local Control (LC) Cumulative Incidence Rates (Phase II) [ Time Frame: 3 and 6 months and 1, 2, and 5 years ] [ Designated as safety issue: No ]
  • Median Time to Progression of Treated Tumors (Phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Refinement of Toxicity and Adverse Events Profile (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Evaluation of Cause of Death (Phase II) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Adverse events profile (Phase I) [ Designated as safety issue: Yes ]
  • Toxicity, per NCI CTCAE v3.0 (Phase I) [ Designated as safety issue: Yes ]
  • Patient clinical response and treatment effects on blood chemistry and hepatic function markers (Phase I) [ Designated as safety issue: No ]
  • Radiographic response rate (Phase II) [ Designated as safety issue: No ]
  • Local control (LC) cumulative incidence rates (Phase II) [ Time Frame: 3 and 6 months and 1, 2, and 5 years ] [ Designated as safety issue: No ]
  • Median time to progression of treated tumors (Phase II) [ Time Frame: 3 and 6 months and 1, 2, and 5 years ] [ Designated as safety issue: No ]
  • Refinement of toxicity and adverse events profile (Phase II) [ Designated as safety issue: Yes ]
  • Refinement of patient clinical response and treatment effects on blood chemistry and hepatic function markers (Phase II) [ Designated as safety issue: No ]
  • Evaluation of cause of death (Phase II) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Unspecified Adult Solid Tumor
  • 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
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.
Interventions:
  • Radiation: stereotactic radiation therapy
  • Procedure: implanted fiducial-based imaging
  • Procedure: cone-beam computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
December 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00938457
MC0941, MC0941, 09-000020, NCI-2009-01150
Yes
Robert C. Miller, M.D., Mayo Clinic Cancer Center
Mayo Clinic
Not Provided
Study Chair: Robert C. Miller, M.D. Mayo Clinic
Mayo Clinic
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP