Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

OHSU Knight Cancer Institute

Status

Terminated

Conditions

Hepatocellular Carcinoma

Treatments

Other: Questionnaire Administration

Radiation: Stereotactic Body Radiation Therapy

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT03812289

NCI-2018-02864 (Registry Identifier)

STUDY00018810 (Other Identifier)

SOL-18142-L

Details and patient eligibility

About

This trial studies how well stereotactic body radiation therapy works in treating patients with liver cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Full description

PRIMARY OBJECTIVE:

I. Assess the use of stereotactic body radiation therapy (SBRT) in hepatocellular carcinoma (HCC) patients with advanced liver cirrhosis as a feasible approach to providing localized disease control that adequately suffices liver transplant eligibility criteria.

SECONDARY OBJECTIVE:

I. Assess preliminary efficacy and toxicity in HCC patients with advanced cirrhosis following liver SBRT.

EXPLORATORY OBJECTIVE:

I. Assess qualify of life in HCC patients with advanced cirrhosis following liver SBRT.

OUTLINE:

Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.

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

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ability to understand and the willingness to sign a written informed consent document
Must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution
Have a Child-Pugh (CP) score >= B8
Eastern Clinical Oncology Group (ECOG) performance status =< 2, or Karnofsky performance scale > 60
Must have a life expectancy > 12 weeks
Safe radiation treatment planning parameters that adhere to all organs at risk constraints per section 5.1 of the protocol. If normal organs at risk constraints (including at least 700cc of uninvolved liver) are unable to be met at the lowest dose modification (30 Gy in 5 fractions), the patient is deemed ineligible for SBRT and deemed a screen failure
Except for prior radiotherapy or radioembolization, other prior therapies to previously treated lesions, are permitted
People of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of SBRT. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year without an alternative medical cause
- Note: Abstinence is acceptable if this is the preferred contraception for the participant
No other prior invasive malignancy is allowed except for the following: adequately treated basal (or squamous cell) skin cancer, in situ breast or cervical cancer. Stage I or II invasive cancer treated with a curative intent without evidence of disease recurrence for at least five years

Exclusion criteria

Participants have any one of the following liver tumor characteristics:
- Have > 5 liver tumors, or
- Maximal diameter > 5 cm
Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
Prior radiotherapy to the upper abdomen or radioembolization of the liver, or prior thermal ablation to the target lesion
For fiducial marker placement:
- Have a gold allergy
- Any coagulopathy preventing safe fiducial placement
Contraindication to both contrast enhanced magnetic resonance imaging (MRI) and contrast enhanced computed tomography (CT) (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
Participation in another concurrent treatment protocol
Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent