Clinical trial NCT04518748: Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
Official title: A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Liver Malignancy
Keywords: Ytrium-90 (Y-90)
Selective Internal Radiation Therapy (SIRT)
Stereotactic Body Radiation Therapy (SBRT)
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2020-08-19
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.

Detailed description: Selective Internal Radiation Therapy (SIRT) is a technique where radiation is internally delivered to a tumor. In SIRT, small radioactive beads are deposited in the liver through a large blood vessel (hepatic artery). SIRT that uses the radioactive material Yttrium-90 is called Y-90 SIRT.

Stereotactic Body Radiation Therapy (SBRT) is a technique where radiation is externally delivered to a tumor. In SBRT, a machine produces a beam of radiation that targets the tumor from outside the body.

After receiving Y-90 SIRT, participants will be evaluated to estimate how much radiation was absorbed by their tumors during Y-90 SIRT. Y-90 PET-CT imaging will be used to help plan SBRT, which will target areas of tumors that did not receive as much radiation as expected during Y-90 SIRT.

Since patients treated with Y-90 for any liver malignancy can benefit from the Y-90+SBRT combined treatment approach we have decided to open up the protocol to all eligible patients and not HCC alone.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following:

  * Biopsy proven hepatocellular carcinoma (HCC); or
  * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria.

Metastatic liver cancer is defined as having:

o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease

* Patients must not have known untreated or progressive disease outside of the liver
* At least one lesion \>2 cm diameter or 4 cc volume
* Patients must have a life expectancy of at least 6 months.
* Patients must be 18 years of age or older
* All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment.
* Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks.

Exclusion Criteria:

* Inability to lie still for imaging studies (e.g. PET/CT)
* Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction.
* Patients with known allergy or contraindication to intravenous iodinated contrast agents
* Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium)
* Contraindication to Theraspheres

  * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques
  * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs.
  * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis;
  * Bilirubin \>2.0 at baseline
  * Occlusion of the main portal vein
* Contraindication to radiation therapy
* Note: Patients who have an increase in bilirubin \>1.0 from the time of Y90 to SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.

Primary outcomes:
measure: Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
timeFrame: Up to 6 months after SBRT
measure: Incidence of toxicities of grade 3 or higher
timeFrame: Up to 6 months after SBRT
measure: Number of patients with a change in albumin + bilirubin (ALBI) level of >= 0.5
timeFrame: Up to 6 months after SBRT
Secondary outcomes:
measure: Freedom from local progression (FFLP) at the lesion level
timeFrame: Until progression or last surveillance scan at approximately 24 months after SBRT
measure: Freedom from local progression (FFLP) at patient level
timeFrame: Until progression or last surveillance scan at approximately 24 months after SBRT
measure: Response rate
timeFrame: Up to 6 months after SBRT
measure: Overall survival
timeFrame: Until death from any cause, or until patient's last follow-up visit, or until study stops; up to approximately 5 years.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Kyle Cuneo, MD
role: PRINCIPAL_INVESTIGATOR
References: