Stereotactic Body Radiation Therapy for Carcinoma, Hepatocellular

1
Effectiveness
1
Safety
OHSU Knight Cancer Institute, Portland, OR
Carcinoma, Hepatocellular+2 More
Stereotactic Body Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether stereotactic body radiation therapy is an effective treatment for liver cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Stereotactic Body Radiation Therapy will improve 1 primary outcome, 7 secondary outcomes, and 3 other outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of At transplantation.

At transplantation
Proportion of histopathologic changes in irradiated tumor sites relative to uninvolved liver tissue
Year 2
Change in QoL scores for Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire
Change in quality of life (QoL) score using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire
Month 3
Incidence of non-classic radiation-induced liver disease (RILD) defined as grade 4 aspartate aminotransferase or alanine aminotransferase elevation, or an increase in Child Pugh (CP) score of >= 2 within 1 week to 3 months after completing SBRT
Year 2
Overall survival
Year 1
Proportion of participants who are transplanted or with localized disease control per Milan criteria
Year 2
Incidence of progressive disease within or at the planned tumor volume (PTV) margin
Up to time of progression, transplantation, death or 2-years after last SBRT dose, whichever occurs first
Incidence of extrahepatic progressive disease
Incidence of intrahepatic progressive disease
Proportion of participants that proceed to transplantation
Month 3
Incidence of liver toxicity assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (SBRT)

This trial requires 15 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stereotactic Body Radiation Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment (SBRT)Patients undergo SBRT on days 1, 3, 5, 7, and 9 in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to time of progression, transplantation, death or 2-years after last sbrt dose, whichever occurs first for reporting.

Who is running the study

Principal Investigator
N. N.
Nima Nabavizadeh, Principal Investigator
OHSU Knight Cancer Institute

Closest Location

OHSU Knight Cancer Institute - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Have a Child-Pugh (CP) score >= B8
You have a performance status of < 2 or a KPS > 60. show original
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
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
You are able to understand the information provided in this document and are willing to sign it. show original
You must be listed or recommended to be listed for orthotopic liver transplantation at the participating institution. show original
People of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of SBRT show original
Abstinence is acceptable if this is the preferred contraception for the participant. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is carcinoma, hepatocellular?

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Cancers, hepatocellular, of which carcinoma of the liver is the second-largest group, affect about one million people in the United States. Carcinoma of the hepatocellular type is not a common occurrence, accounting for around one third of all hepatoblastomas/hepatoid tumours and about two thirds of all cholangiocarcinomas/sclerosing cholangitis.

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What causes carcinoma, hepatocellular?

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Multiple environmental factors, such as diet, alcohol and tobacco, may contribute to the development of hepatocellular carcinoma. One meta-analysis suggested that excess hepatocellular carcinoma could develop from a hepatitis-B virus (HBV) infection, suggesting a synergistic effect of both factors.

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Can carcinoma, hepatocellular be cured?

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It does not mean that patients can be cured of liver carcinoma, but liver carcinoma can be cured. The mainstay is adequate management, using multidisciplinary approaches and combining the management strategies. In order of treatment, chemotherapy, surgery and radiotherapy are effective means.

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What are the signs of carcinoma, hepatocellular?

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Signs and symptoms of hepatocellular carcinoma include jaundice, abdominal pain, fever, weight loss, nausea, vomiting, lethargy, loss of appetite, anemia and anemia, as well as jaundice and anemia.

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What are common treatments for carcinoma, hepatocellular?

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The present practice of treating some types of HCC with chemotherapeutics, RFI, hormonal therapy, or curative operation is still debated. Based on the data presented, combination chemotherapy may be the preferred treatment for HCC in patients who have not received treatment.

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How many people get carcinoma, hepatocellular a year in the United States?

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Overall, the risk of hepatocellular carcinoma is estimated to be 0.13, which is relatively low when considering its prevalence and mortality. However, the incidence of this carcinoma has steadily increased since the early 1980s and appears to justify a nationwide screening program.

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Does carcinoma, hepatocellular run in families?

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Genetic abnormalities associated with familial HCC may be different from those found in sporadic HCC. Results from a recent clinical trial have implications for the development of diagnostic and prophylactic methods for HCAs.

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Is stereotactic body radiation therapy typically used in combination with any other treatments?

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Stereotactic body radiation therapy is commonly used for treatment of HCC, and the use of radiotherapy with a second modality, with or without chemotherapy, may be the most relevant factors that influence the treatment and prognosis of patients with HCC.

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How does stereotactic body radiation therapy work?

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SBRT is an effective treatment for hepatic tumors, both for locoregional control and disease-free survival. Local complications are well tolerated, but long-term studies are needed to address the potential for long-lasting liver dysfunction.

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What is the primary cause of carcinoma, hepatocellular?

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The cause of carcinoma, hepatocellularis unknown. Possible causes include a chronic inflammatory stimulus or chronic oxidative stress of the liver stimulating chronic cirrhosis with increased tissue fibrosis as the underlying underlying pathogenesis.

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What does stereotactic body radiation therapy usually treat?

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In patients with localized hepatocellular carcinoma who are able to tolerate treatment in a short period of time with very low toxicity and an excellent functional outcome, SBRT achieves comparable efficacy with conventional external-beam techniques. SBRT in HCC patients with larger lesions (≤ 5 cm.) is better absorbed than conventional external-beam techniques, but not as good if doses are restricted. Higher doses, either using SBRT or using external beam techniques with or without additional proton therapy, can be used safely to achieve similar antitumor response but with a reduced risk of toxicity.

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How serious can carcinoma, hepatocellular be?

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A variety of other causes must be excluded before a specific diagnosis can be made. Patients with focal septal, sinus, nodular, or solid hepatoma or with other types of carcinoma can present with advanced stage disease because the disease has already metastasized. Patients with focal solid, nodular, or sinus HCC should also be evaluated carefully to exclude the possibility that the tumor is metastatic. To be certain of the diagnosis of carcinoma, hepatocellular, a biopsy is mandatory. However, the usefulness of a biopsy is less accurate if it is done too early.

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