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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

Tracking Information
First Submitted Date  ICMJE October 9, 2015
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date July 24, 2020
Actual Study Start Date  ICMJE June 3, 2015
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • Collection of biomarkers that may be associated with an immunologic systemic response to SBRT [ Time Frame: Up to 2 years ]
  • DSS [ Time Frame: Up to 2 years ]
  • Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0 [ Time Frame: Up to 2 years ]
  • Infield tumor LC [ Time Frame: Up to 2 years ]
  • OS [ Time Frame: Up to 2 years ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer
Official Title  ICMJE Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adult Hepatocellular Carcinoma
  • Metastatic Malignant Neoplasm in the Liver
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Treatment (MRI-guided Tri-60Co teletherapy SBRT)
Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.
Interventions:
  • Radiation: Image-Guided Adaptive Radiation Therapy
  • Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 3, 2022
Estimated Primary Completion Date June 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683200
Other Study ID Numbers  ICMJE 15-000362
NCI-2015-01665 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
15-000362 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: percy Lee UCLA / Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP