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Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Primary Purpose

Unspecified Adult Solid Tumor

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

stereotactic radiation therapy

implanted fiducial-based imaging

cone-beam computed tomography

About this trial

This is an interventional treatment trial for Unspecified Adult Solid Tumor focused on measuring protocol specific

Eligibility Criteria

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

Inclusion Criteria:

Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy).
One to three metastatic liver lesions =< 5 cm in dimension.
Intrahepatic cholangiocarcinoma is acceptable for inclusion.
Zubrod Performance Status (PS) 0 or 1.
Please contact study investigator and/or consult protocol document for specific details on laboratory criteria.
Life expectancy >= 12 weeks.
MELD (Model for End-Stage Liver Disease) score =< 16.
>= 1000 cc of uninvolved liver parenchyma as determined by the treating physician.
Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology.
Provide informed written consent.
Willingness to return to Mayo Clinic Rochester for follow-up.

Exclusion Criteria:

Pregnant women.
Nursing women.
Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception.
Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration.
Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT.
Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible).
Current diagnosis of hepatocellular carcinoma

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.

Outcomes

Primary Outcome Measures

Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.

Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)

LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.

Secondary Outcome Measures

Toxicity and Adverse Events Profile (Phase I)

Number of patients with a grade >= 3 adverse event. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)

Radiographic Response Rate (Phase II)

Local Control (LC) Cumulative Incidence Rates (Phase II)

Median Time to Progression of Treated Tumors (Phase II)

Refinement of Toxicity and Adverse Events Profile (Phase II)

Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)

Evaluation of Cause of Death (Phase II)

Full Information

NCT ID

NCT00938457

First Posted

July 9, 2009

Last Updated

April 19, 2016

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00938457

Brief Title

Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Official Title

A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

poor accrual

Study Start Date

July 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.

Detailed Description

OUTLINE: This is a phase I/II, dose-escalation study. Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement. Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

6. Conditions and Keywords

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

Unspecified Adult Solid Tumor

Keywords

protocol specific

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

stereotactic radiation therapy

Intervention Description

Patients undergo stereotactic body radiation therapy

Intervention Type

Procedure

Intervention Name(s)

implanted fiducial-based imaging

Intervention Description

radiation therapy treatment planning

Intervention Type

Procedure

Intervention Name(s)

cone-beam computed tomography

Intervention Description

radiation therapy treatment planning

Primary Outcome Measure Information:

Title

Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.

Time Frame

2 months

Title

Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)

Description

Time Frame

At 1 year

Secondary Outcome Measure Information:

Title

Toxicity and Adverse Events Profile (Phase I)

Description

Time Frame

Up to 2 years

Title

Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)

Time Frame

Up to 2 years

Title

Radiographic Response Rate (Phase II)

Time Frame

Up to 2 years

Title

Local Control (LC) Cumulative Incidence Rates (Phase II)

Time Frame

3 and 6 months and 1, 2, and 5 years

Title

Median Time to Progression of Treated Tumors (Phase II)

Time Frame

Up to 5 years

Title

Refinement of Toxicity and Adverse Events Profile (Phase II)

Time Frame

Up to 2 years

Title

Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)

Time Frame

Up to 2 years

Title

Evaluation of Cause of Death (Phase II)

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy). One to three metastatic liver lesions =< 5 cm in dimension. Intrahepatic cholangiocarcinoma is acceptable for inclusion. Zubrod Performance Status (PS) 0 or 1. Please contact study investigator and/or consult protocol document for specific details on laboratory criteria. Life expectancy >= 12 weeks. MELD (Model for End-Stage Liver Disease) score =< 16. >= 1000 cc of uninvolved liver parenchyma as determined by the treating physician. Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology. Provide informed written consent. Willingness to return to Mayo Clinic Rochester for follow-up. Exclusion Criteria: Pregnant women. Nursing women. Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception. Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration. Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT. Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible). Current diagnosis of hepatocellular carcinoma

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert C. Miller, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

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Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

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