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Trial record 3 of 67 for:    liver proton

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2016 by Joon-Hyeok Lee, Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Joon-Hyeok Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02632864
First received: December 7, 2015
Last updated: January 12, 2016
Last verified: January 2016
  Purpose

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).


Condition Intervention Phase
Liver Neoplasm Proton Therapy Radiation: Proton arm Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Joon-Hyeok Lee, Samsung Medical Center:

Primary Outcome Measures:
  • two-year overall survival [ Time Frame: two-year after proton beam therapy ]

Secondary Outcome Measures:
  • 1 month objective response rate [ Time Frame: 1 month after proton beam therapy ]
    Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.

  • 3 month objective response rate [ Time Frame: 3 months after proton beam therapy ]
    Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.

  • 6 month objective response rate [ Time Frame: 6 months after proton beam therapy ]
    Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.

  • 1 year progression free survival [ Time Frame: one-year after proton beam therapy ]
    Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.

  • 1 year local progression free survival [ Time Frame: one-year after proton beam therapy ]
    Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.

  • 6 months adverse event [ Time Frame: 6 months after proton beam therapy ]
    Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.

  • 1 year adverse event [ Time Frame: 1 year after proton beam therapy ]
    Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.

  • Baseline Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30) [ Time Frame: Within 2 week before proton beam therapy started ]
  • 1 month Quality of life assessment by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ C-30) compared with baseline [ Time Frame: 1 month after proton beam therapy ]
  • 3 month Quality of life assessment by EORTC QLQ C-30 compared with baseline [ Time Frame: 3 month after proton beam therapy ]
  • 6 month Quality of life assessment by EORTC QLQ C-30 compared with baseline [ Time Frame: 6 month after proton beam therapy ]
  • Baseline Indocyanine green (ICG) [ Time Frame: Within 2 week before proton beam therapy started ]
    ICG Retention rate at 15 minute will be used.

  • Indocyanine green (ICG) test change compared with baseline [ Time Frame: 3 month after proton beam therapy ]
    ICG Retention rate at 15 minute will be used.

  • Baseline hepatobiliary phase signal [ Time Frame: Within 2 week before proton beam therapy started ]
    Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.

  • Hepatobiliary phase signal change after proton beam therapy [ Time Frame: 3 month after proton beam therapy ]
    Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.


Estimated Enrollment: 66
Study Start Date: December 2015
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton arm
Proton beam therapy
Radiation: Proton arm
Proton beam therapy

  Eligibility

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

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02632864

Contacts
Contact: Joon Hyeok Lee, MD, PhD 82-2-3410-3409 gijhlee.lee@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Joon Hyeok Lee, MD, PhD    82-2-3410-3409    gijhlee.lee@samsung.com   
Contact: Hee Chul Park, MD, PhD    82-2-3410-2612    hee.ro.park@samsung.com   
Sub-Investigator: Jeong Il Yu, MD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Joon Hyeok Lee, MD, PhD Samsung Medical Center
  More Information

Responsible Party: Joon-Hyeok Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02632864     History of Changes
Other Study ID Numbers: 2015-08-004
Study First Received: December 7, 2015
Last Updated: January 12, 2016

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on August 18, 2017