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

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ClinicalTrials.gov Identifier: NCT02571946
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Liver Neoplasm Portal Vein Tumor Thrombosis Proton Therapy Radiation: Proton beam therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Proton beam radiotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of High Dose Proton Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Prospective Phase II Trial
Actual Study Start Date : August 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Proton beam therapy Radiation: Proton beam therapy



Primary Outcome Measures :
  1. one-year overall survival [ Time Frame: one-year after proton beam therapy ]

Secondary Outcome Measures :
  1. 1 month objective response rate [ Time Frame: 1 month after proton beam therapy ]
  2. 3 month objective response rate [ Time Frame: 3 months after proton beam therapy ]
  3. 1 month portal vein tumor thrombosis response rate [ Time Frame: 1 month after proton beam therapy ]
  4. 3 month portal vein tumor thrombosis response rate [ Time Frame: 3 month after proton beam therapy ]
  5. 1 year progression free survival [ Time Frame: one-year after proton beam therapy ]
  6. 1 year local progression free survival [ Time Frame: one-year after proton beam therapy ]
  7. 1 year portal vein tumor thrombosis progression free survival [ Time Frame: one-year after proton beam therapy ]
  8. Adverse event [ Time Frame: one-year after proton beam therapy ]
  9. 1 month Quality of life assessment compared with baseline [ Time Frame: 1 month after proton beam therapy ]
  10. 3 month Quality of life assessment compared with baseline [ Time Frame: 3 month after proton beam therapy ]
  11. 6 month Quality of life assessment compared with baseline [ Time Frame: 6 month after proton beam therapy ]
  12. Indocyanine green test change compared with baseline [ Time Frame: 3 month after proton beam therapy ]
  13. Hepatobiliary phase signal change after proton beam therapy [ Time Frame: 3 month after proton beam therapy ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571946


Contacts
Contact: Hee Chul Park, MD, PhD 82-2-3410-2612 hee.ro.park@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hee Chul Park, M.D., Ph.D.    82-2-3410-2612    hee.ro.park@samsung.com   
Principal Investigator: Hee Chul Park, M.D., Ph.D.         
Sub-Investigator: Doo Ho Choi, M.D., Ph.D.         
Sub-Investigator: Jeong Il Yu, M.D.         
Sub-Investigator: Won Ki Kang, M.D., Ph.D.         
Sub-Investigator: Ho Yeong Lim, M.D., Ph.D.         
Sub-Investigator: Young Suk Park, M.D., Ph.D.         
Sub-Investigator: Joon Oh Park, M.D., Ph.D.         
Sub-Investigator: Se Hoon Park, M.D., Ph.D.         
Sub-Investigator: Jeeyun Lee, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02571946     History of Changes
Other Study ID Numbers: 2015-06-053
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Carcinoma, Hepatocellular
Thrombosis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases