A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
18 Years
N/A
Both
Metastatic Cancer
Trial Information
A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose
Safety Issue:
Yes
Principal Investigator
Laura A. Vallow, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000579232
NCT ID:
NCT00567970
Start Date:
April 2007
Completion Date:
Related Keywords:
- Metastatic Cancer
- liver metastases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Liver Neoplasms
Name | Location |
|---|---|
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
