Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01963429
Previous Study | Return to List | Next Study

Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01963429
Recruitment Status : Recruiting
First Posted : October 16, 2013
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Joong-Won Park, National Cancer Center, Korea

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

Condition or disease Intervention/treatment Phase
Recurrent Small Hepatocellular Carcinoma Residual Small Hepatocellular Carcinoma Procedure: radiofrequency ablation Radiation: Proton beam therapy Not Applicable

Detailed Description:

The sample size for this study was based on a non-inferiority design. Primary objective: estimate local progression-free survival (LPFS) rate in two treatments Primary endpoint: 2-year LPFS rate Expected 2-year LPFS rate in the RFA: 85% Accural time and follow up time: 24 months and 24 months, respectively. Precision for 2-year LPFS rate estimation: Allowing a difference of 15% as the non-inferiority margin, with a power of 80% and a type I error level of 5%, evaluable 68 patients are required.

Considering 5% of follow-up loss, we need 72 patients in each arm, so a total of 144 patients will be enrolled.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of the Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation in Patients With Recurrent/Residual Small Hepatocellular Carcinoma (APROH Study)
Actual Study Start Date : September 30, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: A(radiofrequency ablation )
radiofrequency ablation
 Procedure: radiofrequency ablation

* RFA(radiofrequency ablation )

  • RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea)
  • performed using either the manufacturer's standard algorithm or an interactive algorithm, with the latter being used when the impedance did not begin to increase at the midinterval of the standard algorithm
  • the duration of a single RFA session was 10 min to 15 min.
Experimental: B(Proton)
hypofractionated proton beam therapy
 Radiation: Proton beam therapy

* Proton

66 GyE /10 fx, 6.6 GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume),TLV30<40%,and/orRLV30<30%)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. local progression-free survival(LPES) [ Time Frame: up to 2 year ]
    To evaluate the local progression-free survival (1cm from ablation cavity or 1.5cm form gross tumor) for 2 years


Secondary Outcome Measures :
  1. disease-free survival (DFS) [ Time Frame: up to 2 years until study closed ]
    Disease-free survival was defined as the interval from the date of randomization to date of detection study closed


Other Outcome Measures:
  1. overall survival (OS) [ Time Frame: up to 2 years until study closed ]
    Overall survival(OS) was defined as the interval from the date of randomization to date of detection study closed


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation
  • HCC patients who had recurrent or residual tumor after other treatments
  • without evidence of extrahepatic metastasis
  • the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2
  • no previous treatment to target tumors by other forms of RT
  • liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7)
  • Age of ≥18 years
  • performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
  • WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no ascites)
  • no serious comorbidities other than liver cirrhosis
  • written informed consent

Exclusion Criteria:

  • evidence of extrahepatic metastasis
  • age < 18 years
  • liver function of Child-Pugh class B8-9 and C (Child-Pugh score of >7) or uncontrolled cases of active chronic hepatitis B
  • previous history of other forms of RT adjacent to target tumors
  • poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
  • pregnant or breast feeding status
  • previous history uncontrolled other malignancies within 2 years
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01963429


Contacts
Layout table for location contacts
Contact: Joong Won Park, Ph.D +82-31-920-1605 jwpark1@ncc.re.kr
Contact: Tae Hyun Kim, Ph.D +82-31-920-1725 k2onco@ncc.re.kr

Locations
Layout table for location information
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Joong Won Park, Ph.D    +82-31-920-1605    jwpark1@ncc.re.kr   
Contact: Tae Hyun Kim, Ph.D    +82-31-920-1725    k2onco@ncc.re.kr   
Sub-Investigator: Tae Hyun Kim, Ph.D         
Sub-Investigator: Young Hwan Koh, Ph.D         
Sub-Investigator: Ju Hee Lee, Ph.D         
Sub-Investigator: Chang Min Kim, Ph.D         
Sub-Investigator: Bo Hyun Kim, Ph.D         
Sub-Investigator: Min Ju Kim, Ph.D         
Sub-Investigator: Bung Ho Nam, Ph.D         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Layout table for investigator information
Principal Investigator: Joong Won Park, Ph.D National Cancer Center, Korea
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Joong-Won Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01963429    
Other Study ID Numbers: NCCCTS 13-695
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Joong-Won Park, National Cancer Center, Korea:
hepatocellular
Proton
RFA
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases