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

Primary Purpose

Adult Hepatocellular Carcinoma, Metastatic Malignant Neoplasm in the Liver

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Image-Guided Adaptive Radiation Therapy

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Adult Hepatocellular Carcinoma

Eligibility Criteria

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

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

Sites / Locations

UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (MRI-guided Tri-60Co teletherapy SBRT)

Arm Description

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

Outcomes

Primary Outcome Measures

Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy.

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

Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system

Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system

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

Secondary Outcome Measures

Collection of biomarkers that may be associated with an immunologic systemic response to SBRT

DSS

Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0

Infield tumor LC

Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained

Full Information

NCT ID

NCT02683200

First Posted

October 9, 2015

Last Updated

February 16, 2023

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02683200

Brief Title

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

Official Title

Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 3, 2015 (Actual)

Primary Completion Date

January 1, 2022 (Actual)

Study Completion Date

January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Adult Hepatocellular Carcinoma, Metastatic Malignant Neoplasm in the Liver

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (MRI-guided Tri-60Co teletherapy SBRT)

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

Image-Guided Adaptive Radiation Therapy

Other Intervention Name(s)

IGART

Intervention Description

Undergo MRI-guided Tri-60Co teletherapy SBRT

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Other Intervention Name(s)

SBRT

Intervention Description

Undergo MRI-guided Tri-60Co teletherapy SBRT

Primary Outcome Measure Information:

Title

Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy.

Description

Time Frame

Up to 2 years

Title

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

Title

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

Title

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

Title

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 Measure Information:

Title

Collection of biomarkers that may be associated with an immunologic systemic response to SBRT

Time Frame

Up to 2 years

Title

DSS

Time Frame

Up to 2 years

Title

Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0

Time Frame

Up to 2 years

Title

Infield tumor LC

Time Frame

Up to 2 years

Title

Time Frame

Up to 2 years

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ann Raldow, MD

Organizational Affiliation

UCLA / Jonsson Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UCLA / Jonsson Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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