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Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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ClinicalTrials.gov Identifier: NCT00567970
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:

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 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
Metastatic Cancer Procedure: quality-of-life assessment Radiation: stereotactic body radiation therapy Phase 1

Detailed Description:

OBJECTIVES:

  • To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
  • To determine the toxicity and adverse events profile of this patient population.
  • To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.

OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).

Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.

Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.

After completion of study treatment, patients are followed for at least 8 weeks.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
Actual Study Start Date : April 2, 2007
Actual Primary Completion Date : February 2, 2009
Actual Study Completion Date : April 21, 2016



Primary Outcome Measures :
  1. Maximum tolerated dose

Secondary Outcome Measures :
  1. Toxicity profile
  2. Adverse events profile
  3. Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
  4. Response profile
  5. Physical exam results


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Metastatic liver lesion ≤ 5 cm in dimension
  • Willing and able to undergo percutaneous placement of localization seeds

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 12 weeks
  • Platelet count ≥ 75,000/µL
  • Hemoglobin ≥ 9 g/dL
  • ANC ≥ 1,500/mL
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST ≤ 3 x ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to complete questionnaires alone or with assistance
  • No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol

PRIOR CONCURRENT THERAPY:

  • No prior radiation therapy to the liver
  • No chemotherapy ≤ 4 weeks prior to registration
  • Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks [4 weeks prior to and 4 weeks after registration] surrounding stereotactic radiotherapy

Information from the National Library of Medicine

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): NCT00567970


Locations
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura A. Vallow, MD Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00567970     History of Changes
Other Study ID Numbers: CDR0000579232
P30CA015083 ( U.S. NIH Grant/Contract )
MC0642 ( Other Identifier: Mayo Clinic Cancer Center )
06-004336 ( Other Identifier: Mayo Clinic IRB )
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Keywords provided by Mayo Clinic:
liver metastases

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