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

NCT04466124 | Enrolling By Invitation

• 1 other identifier: NCC2018-0197
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cancer

Keywords

Proton Beam Therapy; Cohort Study

Outcome Measures

Primary Outcomes (1)

• Establish a cohort of liver cancer patients treadted with proton beam therapy.

  The primary outcome is to establish a prospective cohort of liver cancer patients treadted with proton beam therapy. It is for exploration of factors and models that predict local control, recurrence, survival and treatment-related toxicity in liver cancer patients undergoing proton therapy.

  Up to 10 years

Interventions

Liver Cancer Patients Treated With Proton Beam Therapy RADIATION

Proton Beam Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Liver cancer patients over the age of 19

You may qualify if:

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

You may not qualify if:

• Disagreed to participate in this study

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Proton Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Study Officials

• Tae Hyun Kim, Ph.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: September 21, 2018
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

KR (1)