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Enrolling by invitation NCT04466124

Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy

Observational Liver Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liver Cancer Patients Treated With Proton Beam Therapy.
Who it may be relevant to
Registry conditions: Liver Cancer. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Cohort Study for Identifying Factors Predicting Clinical Outcomes of Liver Cancer Patients Treated With Proton Beam Therapy

Overview

Liver cancer is the fourth most common malignant tumor in Korea and it is the third most common cause of cancer death worldwide according to the 2009 Korea Central Cancer Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be obtained when surgery is performed including liver transplantation, but most (70-80%) patients with liver cancer are difficult to get surgery due to liver disease associated with cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with cirrhosis, repeated treatment is required. For these reasons, various treatments for liver cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency heat therapy, and radiation therapy) have been performed. Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for liver cancer because it maximizes radiation to tumor tissues and reduces radiation doses from surrounding normal tissues due to the distinct physical properties of proton beams. Promising therapeutic results and less toxicity have been reported in liver cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1, NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to be associated with recurrence and prognosis.

Detailed description

Liver cancer is the fourth most common malignant tumor in Korea and it is the third most common cause of cancer death worldwide according to the 2009 Korea Central Cancer Registration Annual Report. Excellent survival rate (50-70% 5-year survival rate) can be obtained when surgery is performed including liver transplantation, but most (70-80%) patients with liver cancer are difficult to get surgery due to liver disease associated with cirrhosis. In addition, due to the multi-centric nature of liver cancer in patients with cirrhosis, repeated treatment is required. For these reasons, various treatments for liver cancer (percutaneous arterial embolization, percutaneous ethanol injection, radiofrequency heat therapy, and radiation therapy) have been performed.

Due to recent advances in radiotherapy technology, proton beam therapy (PBT) is a promising treatment for liver cancer because it maximizes radiation to tumor tissues and reduces radiation doses from surrounding normal tissues due to the distinct physical properties of proton beams. Promising therapeutic results and less toxicity have been reported in liver cancer. In addition, several genes in liver cancer (SOCS-1, GSTP, APC, VEGF, PD-EGF, HIF-1, NOS, b-FGF, LINE-1, p27, TOP2A, Ets-1, Bcl-xL, Osteopontin, CD44, etc.) have been reported to be associated with recurrence and prognosis. Therefore, in this study, the investigator is going to establish a prospective cohort of liver cancer patients treated with proton beam therapy. It be used for analyzing local control, survival, recurrence, toxicity, proton treatment plan information, gene expression information, then local control (LC), overall survival. (overall survival, OS), recurrence-free surival (RFS), and factors that predict treatment-related toxicity.

Interventions

  • Radiation Liver Cancer Patients Treated With Proton Beam Therapy
    Proton Beam Therapy

Primary outcome measures

  • Establish a cohort of liver cancer patients treadted with proton beam therapy. [Time frame: Up to 10 years]

Eligibility criteria

Inclusion criteria

  • Liver cancer patients scheduled to be proton beam therapy
  • Agreed to participate in this study

Exclusion criteria

-Disagreed to participate in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • National Cancer Center Korea — Goyang-si

Identifiers

NCT: NCT04466124 · NCC2018-0197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗