This trial is active, not recruiting.

Condition metastatic cancer
Treatments quality-of-life assessment, stereotactic body radiation therapy
Phase phase 1
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date April 2007
End date September 2016
Trial size 18 participants
Trial identifier NCT00567970, 06-004336, CDR0000579232, MC0642, P30CA015083


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Maximum tolerated dose
time frame:

Secondary Outcomes

Toxicity profile
time frame:
Adverse events profile
time frame:
Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
time frame:
Response profile
time frame:
Physical exam results
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 120 years old.

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

Additional Information

Official title A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
Principal investigator Laura A. Vallow, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.