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A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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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 - JacksonvilleJacksonville, Florida  32224