Comparison Between Radiofrequency Ablation and Hypofractionated Proton Beam Radiation for Recurrent/Residual HCC
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ClinicalTrials.gov Identifier: NCT01963429 |
Recruitment Status
:
Recruiting
First Posted
: October 16, 2013
Last Update Posted
: March 24, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Small Hepatocellular Carcinoma Residual Small Hepatocellular Carcinoma | Radiation: Proton beam therapy | Phase 3 |
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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A (RFA)
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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 |
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Principal Investigator: | Joong Won Park, Ph.D | National Cancer Center, Korea |
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 Key Record Dates |
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 |