Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

NCT00938457 | Terminated Phase 1 Results DMC

• 3 other identifiers: MC094109-000020NCI-2009-01150
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor

Keywords

protocol specific

Outcome Measures

Primary Outcomes (2)

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

  2 months

• 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.

  At 1 year

Secondary Outcomes (8)

• Toxicity and Adverse Events Profile (Phase I)

  Up to 2 years

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

  Up to 2 years

• Radiographic Response Rate (Phase II)

  Up to 2 years

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

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

• Median Time to Progression of Treated Tumors (Phase II)

  Up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Radiation: stereotactic radiation therapy; Procedure: implanted fiducial-based imaging; Procedure: cone-beam computed tomography

Interventions

stereotactic radiation therapy RADIATION

Patients undergo stereotactic body radiation therapy

Arm I

implanted fiducial-based imaging PROCEDURE

radiation therapy treatment planning

Arm I

cone-beam computed tomography PROCEDURE

radiation therapy treatment planning

Arm I

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Dr. Robert C. Miller
• Organization: Mayo Clinic

miller.robert@mayo.edu

507-284-2669

Study Officials

• Robert C. Miller, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2011
• Last Updated: May 19, 2016
• Results First Posted: July 9, 2012

Record last verified: 2015-10

Locations

US (1)