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Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis (PTHP)

Primary Purpose

Liver Neoplasm, Portal Vein Tumor Thrombosis, Proton Therapy

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Proton beam therapy

About this trial

This is an interventional treatment trial for Liver Neoplasm

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hepatocellular carcinoma (HCC) patients
pathologically proven
HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline
Portal vein tumor thrombosis (main, first branch, segmental)
Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
20 or more age
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
Child-Pugh class A, B, or early C (score ≤ 10)
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
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 and for at least 28 days following the last dose of sorafenib (whichever is later).

Exclusion Criteria:

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

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton beam therapy

Arm Description

Outcomes

Primary Outcome Measures

one-year overall survival

Secondary Outcome Measures

1 month objective response rate

3 month objective response rate

1 month portal vein tumor thrombosis response rate

3 month portal vein tumor thrombosis response rate

1 year progression free survival

1 year local progression free survival

1 year portal vein tumor thrombosis progression free survival

Adverse event

1 month Quality of life assessment compared with baseline

3 month Quality of life assessment compared with baseline

6 month Quality of life assessment compared with baseline

Indocyanine green test change compared with baseline

Hepatobiliary phase signal change after proton beam therapy

Full Information

NCT ID

NCT02571946

First Posted

October 7, 2015

Last Updated

April 18, 2018

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02571946

Brief Title

Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Acronym

PTHP

Official Title

Feasibility of High Dose Proton Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Prospective Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (Actual)

Primary Completion Date

September 2019 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT). With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. 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 those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Neoplasm, Portal Vein Tumor Thrombosis, Proton Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Proton beam radiotherapy

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proton beam therapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Proton beam therapy

Primary Outcome Measure Information:

Title

one-year overall survival

Time Frame

one-year after proton beam therapy

Secondary Outcome Measure Information:

Title

1 month objective response rate

Time Frame

1 month after proton beam therapy

Title

3 month objective response rate

Time Frame

3 months after proton beam therapy

Title

1 month portal vein tumor thrombosis response rate

Time Frame

1 month after proton beam therapy

Title

3 month portal vein tumor thrombosis response rate

Time Frame

3 month after proton beam therapy

Title

1 year progression free survival

Time Frame

one-year after proton beam therapy

Title

1 year local progression free survival

Time Frame

one-year after proton beam therapy

Title

1 year portal vein tumor thrombosis progression free survival

Time Frame

one-year after proton beam therapy

Title

Adverse event

Time Frame

one-year after proton beam therapy

Title

1 month Quality of life assessment compared with baseline

Time Frame

1 month after proton beam therapy

Title

3 month Quality of life assessment compared with baseline

Time Frame

3 month after proton beam therapy

Title

6 month Quality of life assessment compared with baseline

Time Frame

6 month after proton beam therapy

Title

Indocyanine green test change compared with baseline

Time Frame

3 month after proton beam therapy

Title

Hepatobiliary phase signal change after proton beam therapy

Time Frame

3 month after proton beam therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hepatocellular carcinoma (HCC) patients pathologically proven HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline Portal vein tumor thrombosis (main, first branch, segmental) Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist 20 or more age 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 Child-Pugh class A, B, or early C (score ≤ 10) 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 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 and for at least 28 days following the last dose of sorafenib (whichever is later). Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hee Chul Park, MD, PhD

Phone

82-2-3410-2612

hee.ro.park@gmail.com

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact: