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Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Primary Purpose

Metastatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

quality-of-life assessment

stereotactic body radiation therapy

About this trial

This is an interventional treatment trial for Metastatic Cancer focused on measuring liver metastases

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic - Jacksonville

Outcomes

Primary Outcome Measures

Maximum tolerated dose

Secondary Outcome Measures

Toxicity profile

Adverse events profile

Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory

Response profile

Physical exam results

Full Information

NCT ID

NCT00567970

First Posted

December 4, 2007

Last Updated

October 4, 2018

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00567970

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

April 2, 2007 (Actual)

Primary Completion Date

February 2, 2009 (Actual)

Study Completion Date

April 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Cancer

Keywords

liver metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiation therapy

Primary Outcome Measure Information:

Title

Maximum tolerated dose

Secondary Outcome Measure Information:

Title

Toxicity profile

Title

Adverse events profile

Title

Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory

Title

Response profile

Title

Physical exam results

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laura A. Vallow, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic - Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

12. IPD Sharing Statement

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Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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