Proton Stereotactic Body Radiation Therapy for Carcinoma, Hepatocellular

Phase-Based Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Carcinoma, Hepatocellular+9 More
Proton Stereotactic Body Radiation Therapy - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Hepatocellular

Study Summary

This study is evaluating whether stereotactic body proton radiotherapy is effective in treating patients with liver cancer.

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Eligible Conditions

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Stage IA Hepatocellular Carcinoma AJCC v8
  • Stage IB Hepatocellular Carcinoma AJCC v8
  • Recurrent Hepatocellular Carcinoma
  • Stage I Hepatocellular Carcinoma AJCC v8
  • Stage IIIB Hepatocellular Carcinoma AJCC v8
  • Stage II Hepatocellular Carcinoma AJCC v8
  • Stage III Hepatocellular Carcinoma AJCC v8
  • Stage IIIA Hepatocellular Carcinoma AJCC v8

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Proton Stereotactic Body Radiation Therapy will improve 1 primary outcome, 10 secondary outcomes, and 4 other outcomes in patients with Carcinoma, Hepatocellular. Measurement will happen over the course of 3 months.

3 months
3-month complication rate
3-month rate of patients experiencing an increase in Child-Pugh score by 2 or more points of 5-fraction stereotactic body proton radiotherapy in the treatment of hepatocellular carcinoma (HCC)
6 months
6-month local control
Imaging response rates
RECIST criteria will be used to defined local control/local failure
Value of volumetric imaging analysis
Up to 2 years
Blood bank patient specimens for future analysis
Clinical features, treatment technique, and dose-volume parameters
Incidence of late toxicity
Liver disease control
Liver disease control - Intrahepatic failure assessment
Overall survival
Patient-reported outcomes
Progression free survival
Value of additional imaging analyses and techniques

Trial Safety

Trial Design

2 Treatment Groups

Control
Treatment (SBPT)

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Proton 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 in Phase 2 and have already been tested with other people.

Treatment (SBPT)Patients undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Hepatocellular or one of the other 9 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients treated with external beam radiation as a bridge to transplant are allowed
Target lesion must be amenable to a SBRT regimen utilizing proton beam therapy (i.e. SBPT)
Age >= 18 years
Radiologically presumed or histologically proven, newly diagnosed or recurrent, hepatocellular carcinoma
Clinical stage T0-T4N0M0 (American Joint Committee on Cancer [AJCC] 8th edition).
One to three discrete Liver Reporting and Data System-5 (LIRADS-5) lesions that can be encompassed within a single radiation treatment plan
Minimum single lesion size >= 1 cm, maximum cumulative diameter =< 15 cm
Vascular involvement (including portal vein, inferior vena cava [IVC] and/or hepatic vein) is allowed
Prior local liver treatment including surgery, percutaneous ablation, transarterial bland or chemoembolization (TACE), or Y-90 radioembolization is allowed if completed at least 6 weeks prior to treatment start date
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2

Patient Q&A Section

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

Can carcinoma, hepatocellular be cured?

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To summarize, although the tumor size and the degree of hepatic function are of great significance for the prognosis and survival of HCC patients, the BCLC staging system has been proven to be still a good surrogate in predicting overall survival after TACE treatment.

Unverified Answer

What is carcinoma, hepatocellular?

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[Chronic hepatitis (CH) and alcoholic cirrhosis (AC) are often associated with [hepatocellular carcinoma] (HCC). HCC is a main cause of death in CH and AC patients. HCCs should be considered as a new entity and should receive higher priority when planning treatment in chronic hepatitis patients.

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

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Approximately 713200 cases of carcinoma, hepatocellular occur each year in the United States. However, many of these cases do not develop into cancer. Therefore, in the United States, only a very small proportion of carcinoma, hepatocellular is the product of the initiation process alone. Most cases are the consequence of other factors not currently under my investigation.

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What are common treatments for carcinoma, hepatocellular?

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For a selected group of patients with localized HCC that were amenable to either surgical resection or ablation, combined modality therapy such as chemotherapy before or during hepatectomy has shown benefit in terms of overall survival and recurrence-free survival. Although radiation therapy can be used as part of neoadjuvant therapy and/or adjuvant therapy after curative hepatectomy, a recent phase III study by the American Joint Committee on Cancer (AJCC) revealed no significant difference in overall cancer-specific survival (CSSS) or disease-free survival between the use of post-surgery postoperative radiotherapy versus only post-surgery chemotherapy for HCC after curative surgery.

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What are the signs of carcinoma, hepatocellular?

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The signs and symptoms of carcinoma (especially HCC) are similar to those of chronic viral hepatitis and cirrhosis. These include fatigue, malaise, weight loss, anemia, abdominal pain, hepatomegaly, fever, and leukocytosis. The underlying mechanisms of these signs are usually due to secondary infections.

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What causes carcinoma, hepatocellular?

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Although various infectious agents can cause hepatocarcinogenesis, no single agent has been identified. The identification of environmental factors that promote hepatocarcinogenesis is crucial to the development of strategies to halt/reverse its occurrence.

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What are the latest developments in proton stereotactic body radiation therapy for therapeutic use?

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Stereotactic body radiation treatments are rapidly expanding into a full suite of specialized proton beam treatments. This technology offers treatment options, and potential improvements in patient selection, dose escalation, tumor response and tolerability.

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How serious can carcinoma, hepatocellular be?

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Survival and recurrence of HCC is poor after curative treatments, whereas it is relatively lower in the case of cirrhotic patients. The underlying underlying mechanism may be due to liver tumor growth or the infiltration of cancerous cells into the portal vein. [Hepatocellular carcinoma is one of the leading cancers in terms of prevalence and mortality among the noncommunicable diseases in China. In the last 40 years, the incidence of HCC has steadily increased, but the prognosis of patients is still very poor. The mortality rate can be up to 70%.] Given the high prevalence of cirrhosis in China, HCC tends to become highly prevalent in a population.

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Who should consider clinical trials for carcinoma, hepatocellular?

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The high-risk patient group should be the prime target for clinical trials. Patient selection and careful inclusion criteria will enhance quality of life and survival.

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Have there been other clinical trials involving proton stereotactic body radiation therapy?

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The authors' results are consistent with the earlier published results of two previous studies. The earlier studies are at better quality, however, all three are consistent with conclusions from studies published previously.

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What is the primary cause of carcinoma, hepatocellular?

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Infectious and non-infectious causes for HCC have been described. The most common, if not the only, cause of HCC is chronic HBV infection (70%). Other known risk factors for HCC include a history of cirrhosis (5.4%) from HBV, HCV, or alcohol use (2.7%); and alcohol use alone (3.9%).

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What are the common side effects of proton stereotactic body radiation therapy?

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The side effects observed during SBRT are fairly common. Most of these side effects are dose related and require close monitoring. The most common side effects are nausea and vomiting, diarrhea, and fatigue. The majority of these side effects occurred within the first week after treatment. More recently we found that most of the side effects are controllable and can lead to dose reduction with close monitoring of long-term outcomes.

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