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

Recurrent Small Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963429
• Other study ID #: NCCCTS 13-695
• Status: Completed
• Phase: N/A
• Start date: September 30, 2013
• Est. completion date: January 20, 2020

Study information

• Verified date: October 2020
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 3 study is to evaluate the effectiveness of the comparison between radiofrequency ablation and hypofractionated proton beam radiation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Recurrent Small Hepatocellular Carcinoma
• Residual Small Hepatocellular Carcinoma

Intervention

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.

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%)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center, Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	overall survival (OS)	Overall survival(OS) was defined as the interval from the date of randomization to date of detection study closed	up to 2 years until study closed
Primary	local progression-free survival(LPES)	To evaluate the local progression-free survival for 2 years	up to 2 year
Secondary	disease-free survival (DFS)	Disease-free survival was defined as the interval from the date of randomization to date of detection study closed	up to 2 years until study closed