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
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: July 2009
Study Completion Date: December 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 therapy
Procedure: implanted fiducial-based imaging
radiation therapy treatment planning
Procedure: cone-beam computed tomography
radiation therapy treatment planning

Detailed Description:

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938457

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Robert C. Miller, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert C. Miller, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00938457     History of Changes
Other Study ID Numbers: MC0941, MC0941, 09-000020, NCI-2009-01150
Study First Received: July 9, 2009
Results First Received: June 4, 2012
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014