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Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Proton Beam Therapy

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments.
without evidence of extrahepatic metastasis
All target tumors must be encompassable within single irradiation field (15x15 cm maximum)
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 ≥ 25,000/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)
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
multicentric HCCs, except for those with the following two conditions: *multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) *lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proton Beam Therapy

Arm Description

Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 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%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30<50% and RLV30<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30<60%, and/or RLV30<50% Dose prescription : 95% isodose volume of prescribed dose encompassed PTV

Outcomes

Primary Outcome Measures

local progression-free survival

To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.

Secondary Outcome Measures

overall survival

To evaluate compliance of proton beam radiotherapy for HCC by analyzing acute and late treatment-related toxicity, such as radiation-induced hepatic toxicity and gastrointestinal tract toxicity To evaluate the impact of hypofractionated proton beam radiotherapy for HCC by analyzing the tumor response rate, local disease-free survival (DFS) and overall survival (OS) rate

Full Information

NCT ID

NCT01643824

First Posted

July 12, 2012

Last Updated

August 21, 2018

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT01643824

Brief Title

Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

Official Title

A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

June 7, 2012 (undefined)

Primary Completion Date

April 30, 2017 (Actual)

Study Completion Date

April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for HCC patients in hepatitis B endemic area.

Detailed Description

The primary endpoint is local progression free survival. The trial is a single arm phase II trial with the historical arm. The expected 3-year local progression free survival for patient with HCC patients treated with proton beam therapy would be 80%. With a power of 80% and a type I error level of 10%, evaluable 40 patients are required to reject that the null hypothesis that true 3-year local progression free survival rate is ≤65%. Considering the 10% unevaluable patients due to loss of follow up, a total 45 eligible patients for each arms will be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Proton Beam Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Proton Beam Therapy

Other Intervention Name(s)

Radiotherapy

Intervention Description

- Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 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%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30<50% and RLV30<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30<60%, and/or RLV30<50% - Dose prescription : 95% isodose volume of prescribed dose encompassed PTV

Primary Outcome Measure Information:

Title

local progression-free survival

Description

To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.

Time Frame

Up to 1 year

Secondary Outcome Measure Information:

Title

overall survival

Description

Time Frame

Up to 2years until study closed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments. without evidence of extrahepatic metastasis All target tumors must be encompassable within single irradiation field (15x15 cm maximum) 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 ≥ 25,000/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) 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 multicentric HCCs, except for those with the following two conditions: *multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) *lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae Hyun Kim, Ph.D

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-do

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

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