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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Early Phase 1

Conditions

Adult Hepatocellular Carcinoma

Metastatic Malignant Neoplasm in the Liver

Treatments

Radiation: Image-Guided Adaptive Radiation Therapy

Radiation: Stereotactic Body Radiation Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02683200

NCI-2015-01665 (Registry Identifier)

15-000362 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No 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