Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Phase 1

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT00567970
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2007-04-02
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Primary Completion: 2009-02-02
• Study Completion: 2016-04-21
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose

Secondary Outcome Measures

Name	Time	Method
Physical exam results
Adverse events profile
Toxicity profile
Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
Response profile

Trial Locations

Locations (1)

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States