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Trial record 1 of 1 for:    NCT01963429
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Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Joong-Won Park, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01963429
First received: October 13, 2013
Last updated: March 22, 2015
Last verified: March 2015
  Purpose
This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

Condition Intervention Phase
Recurrent Small Hepatocellular Carcinoma
Residual Small Hepatocellular Carcinoma
Radiation: Proton beam therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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


Estimated Enrollment: 144
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (RFA)
  1. RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea)
  2. 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
Radiation: Proton beam therapy
Experimental: Arm B (Proton)
66 GyE /10 fx, 6.6GyE 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/or RLV30<30%)
Radiation: Proton beam therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: NCT01963429

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
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
Principal Investigator: Joong Won Park, Ph.D National Cancer Center, Korea
  More Information

Responsible Party: Joong-Won Park, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01963429     History of Changes
Other Study ID Numbers: NCCCTS 13-695 
Study First Received: October 13, 2013
Last Updated: March 22, 2015

Keywords provided by National Cancer Center, Korea:
hepatocellular
Proton
RFA

Additional relevant 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

ClinicalTrials.gov processed this record on February 20, 2017