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

Study Description

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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	Radiation: Proton beam therapy	Phase 3

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

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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)
Study Start Date :	October 2013
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Arm A (RFA); 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	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

Outcome Measures

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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

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	October 16, 2013
Last Update Posted:	March 24, 2015
Last Verified:	March 2015

Keywords provided by Joong-Won Park, 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