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MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683200
Recruitment Status : Active, not recruiting
First Posted : February 17, 2016
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.

Condition or disease Intervention/treatment Phase
Adult Hepatocellular Carcinoma Metastatic Malignant Neoplasm in the Liver Radiation: Image-Guided Adaptive Radiation Therapy Radiation: Stereotactic Body Radiation Therapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).

II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions.

SECONDARY OBJECTIVES:

I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).

II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.

OUTLINE:

Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.

After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System
Actual Study Start Date : June 3, 2015
Estimated Primary Completion Date : June 3, 2021
Estimated Study Completion Date : June 3, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (MRI-guided Tri-60Co teletherapy SBRT)
Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.
Radiation: Image-Guided Adaptive Radiation Therapy
Undergo MRI-guided Tri-60Co teletherapy SBRT
Other Name: IGART

Radiation: Stereotactic Body Radiation Therapy
Undergo MRI-guided Tri-60Co teletherapy SBRT
Other Name: SBRT




Primary Outcome Measures :
  1. Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy. [ Time Frame: Up to 2 years ]
    Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion

  2. Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities [ Time Frame: Up to 2 years ]
  3. Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system [ Time Frame: Up to 2 years ]
  4. Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system [ Time Frame: Up to 2 years ]
  5. Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI [ Time Frame: Up to 2 tears ]

Secondary Outcome Measures :
  1. Collection of biomarkers that may be associated with an immunologic systemic response to SBRT [ Time Frame: Up to 2 years ]
  2. DSS [ Time Frame: Up to 2 years ]
  3. Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0 [ Time Frame: Up to 2 years ]
  4. Infield tumor LC [ Time Frame: Up to 2 years ]
  5. OS [ Time Frame: Up to 2 years ]
  6. Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
  • Karnofsky performance status (KPS) >= 70
  • No active infections requiring systemic antibiotics
  • If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
  • Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

  • Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
  • Refusal to sign the informed consent
  • Patients who are participating in a concurrent treatment protocol
  • Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683200


Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Eli Lilly and Company
Investigators
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Principal Investigator: percy Lee UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02683200    
Other Study ID Numbers: 15-000362
NCI-2015-01665 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-000362 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases