search
Back to results

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

Primary Purpose

Liver Neoplasm, Proton Therapy

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Proton arm
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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 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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton arm

Arm Description

Proton beam therapy

Outcomes

Primary Outcome Measures

two-year overall survival

Secondary Outcome Measures

1 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
3 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
6 month objective response rate
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
1 year progression free survival
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
1 year local progression free survival
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
6 months adverse event
Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.
1 year adverse event
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)
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
3 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
6 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Baseline Indocyanine green (ICG)
ICG Retention rate at 15 minute will be used.
Indocyanine green (ICG) test change compared with baseline
ICG Retention rate at 15 minute will be used.
Baseline hepatobiliary phase signal
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.
Hepatobiliary phase signal change after proton beam therapy
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.

Full Information

First Posted
December 7, 2015
Last Updated
April 11, 2018
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02632864
Brief Title
Feasibility of High Dose PROton Therapy On Unresectable Primary Carcinoma Of Liver: Prospective Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasm, Proton Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton arm
Arm Type
Experimental
Arm Description
Proton beam therapy
Intervention Type
Radiation
Intervention Name(s)
Proton arm
Intervention Description
Proton beam therapy
Primary Outcome Measure Information:
Title
two-year overall survival
Time Frame
two-year after proton beam therapy
Secondary Outcome Measure Information:
Title
1 month objective response rate
Description
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Time Frame
1 month after proton beam therapy
Title
3 month objective response rate
Description
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Time Frame
3 months after proton beam therapy
Title
6 month objective response rate
Description
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Time Frame
6 months after proton beam therapy
Title
1 year progression free survival
Description
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Time Frame
one-year after proton beam therapy
Title
1 year local progression free survival
Description
Modified Response Evaluation Criteria In Solid Tumors (mRECIST) will be used.
Time Frame
one-year after proton beam therapy
Title
6 months adverse event
Description
Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.
Time Frame
6 months after proton beam therapy
Title
1 year adverse event
Description
Common Terminology Criteria for Adverse Event v4.0 (CTCAE v4.0) will be used.
Time Frame
1 year after proton beam therapy
Title
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
Title
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
Title
3 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Time Frame
3 month after proton beam therapy
Title
6 month Quality of life assessment by EORTC QLQ C-30 compared with baseline
Time Frame
6 month after proton beam therapy
Title
Baseline Indocyanine green (ICG)
Description
ICG Retention rate at 15 minute will be used.
Time Frame
Within 2 week before proton beam therapy started
Title
Indocyanine green (ICG) test change compared with baseline
Description
ICG Retention rate at 15 minute will be used.
Time Frame
3 month after proton beam therapy
Title
Baseline hepatobiliary phase signal
Description
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.
Time Frame
Within 2 week before proton beam therapy started
Title
Hepatobiliary phase signal change after proton beam therapy
Description
Hepatobiliary phase (20 minute after gadoxetate disodium injection) will be used to evaluate functioning liver volume.
Time Frame
3 month after proton beam therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon Hyeok Lee, MD, PhD
Phone
82-2-3410-3409
Email
gijhlee.lee@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Hyeok Lee, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joon Hyeok Lee, MD, PhD
Phone
82-2-3410-3409
Email
gijhlee.lee@samsung.com
First Name & Middle Initial & Last Name & Degree
Hee Chul Park, MD, PhD
Phone
82-2-3410-2612
Email
hee.ro.park@samsung.com
First Name & Middle Initial & Last Name & Degree
Jeong Il Yu, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs