Clinical trial NCT00567970: Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
Official title: A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Cancer
Keywords: liver metastases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-05
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Maximum tolerated dose
Secondary outcomes:
measure: Toxicity profile
measure: Adverse events profile
measure: Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
measure: Response profile
measure: Physical exam results
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Laura A. Vallow, MD
role: PRINCIPAL_INVESTIGATOR
References: