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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local progression-free survival

Outcome Description:

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

Outcome Time Frame:

Up to 1 year

Safety Issue:

Yes

Principal Investigator

Tae Hyun Kim, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS-12-622

NCT ID:

NCT01643824

Start Date:

June 2012

Completion Date:

April 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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