Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial

NCT02632864 | Unknown Phase 2

• 1 other identifier: 2015-08-004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment of unresectable hepatocellular carcinoma (HCC) is transarterial chemoembolization (TACE) or sorafenib. Though the TACE and the agent showed survival benefit in several randomized phase III trials, the benefit was modest. Recently, radiotherapy (RT), especially conformal and higher dose with the advancement of RT techniques, showed favorable response rate with acceptable local control rate. Based on those promising results, RT was actively applied in HCC who are not indicated with surgery and/or radiofrequency ablation. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose. Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively. In this background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients who are not indicated with surgery and/or radiofrequency ablation (RFA).

Conditions

Liver Neoplasm; Proton Therapy

Outcome Measures

Primary Outcomes (1)

• two-year overall survival

  two-year after proton beam therapy

Secondary Outcomes (15)

• 1 month objective response rate

  1 month after proton beam therapy

• 3 month objective response rate

  3 months after proton beam therapy

• 6 month objective response rate

  6 months after proton beam therapy

• 1 year progression free survival

  one-year after proton beam therapy

• 1 year local progression free survival

  one-year after proton beam therapy

Study Arms (1)

Proton arm

EXPERIMENTAL

Proton beam therapy

Radiation: Proton arm

Interventions

Proton arm RADIATION

Proton beam therapy

Proton arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatocellular carcinoma (HCC) patients (Pathologically proven or HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline)
• Not indicated with surgical resection and/or RFA
• Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
• Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
• Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
• Adequate liver/renal function within 1 week before participate
• Total bilirubin \<3.0 mg/dL, Prothrombin time/International normalized ratio \<1.7, Albumin≥2.8g/dL, Aspartate aminotransferase/alanine aminotransferase\<6 times of upper normal limit Serum creatinine \< 1.5 x upper normal limit, glomerular filtration rate \> 50 ml/min
• Informed consent
• If viable tumor is single, 1 cm to 10 cm
• Less than 3 nodules
• Child-Pugh class A, B, or early C (score ≤ 10)
• Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT

You may not qualify if:

• Uncontrolled hepatic encephalopathy
• Previous history of upper abdominal radiotherapy
• Status of pregnancy or breast feeding
• Less than 12 weeks of expected survival
• Uncontrolled ascites
• Combined with disease known as radiosensitive disorder (connective tissue disorder, Ataxia-telangiectasia)
• Hard to maintain stable respiration less than 5 minutes related with respiratory disease
• Combined with uncontrolled severe acute disease other than liver

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Joon Hyeok Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joon Hyeok Lee, MD, PhD

CONTACT

82-2-3410-3409; gijhlee.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: November 1, 2022
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

KR (1)