Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00567970
First received: December 4, 2007
Last updated: March 24, 2014
Last verified: March 2014
  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 trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.


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

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity profile [ Designated as safety issue: Yes ]
  • Adverse events profile [ Designated as safety issue: Yes ]
  • Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory [ Designated as safety issue: No ]
  • Response profile [ Designated as safety issue: No ]
  • Physical exam results [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: April 2007
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00567970

Locations
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Laura A. Vallow, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Laura A Vallow, M.D., Mayo Clinic in Florida
ClinicalTrials.gov Identifier: NCT00567970     History of Changes
Other Study ID Numbers: CDR0000579232, P30CA015083, MC0642, 06-004336
Study First Received: December 4, 2007
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
liver metastases

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

ClinicalTrials.gov processed this record on October 19, 2014