Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Tae Hyun Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01643824
First received: July 12, 2012
Last updated: May 26, 2014
Last verified: May 2014

July 12, 2012
May 26, 2014
June 2012
April 2016   (final data collection date for primary outcome measure)
local progression-free survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
Same as current
Complete list of historical versions of study NCT01643824 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: Up to 2years until study closed ] [ Designated as safety issue: No ]
  • 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
Same as current
Not Provided
Not Provided
 
Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

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

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
Radiation: Proton Beam Therapy

- 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

Other Name: Radiotherapy
Experimental: Proton Beam Therapy
Intervention: Radiation: Proton Beam Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
135
April 2016
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Tae Hyun Kim, Ph.D +82-31-920-1725 k2onco@ncc.re.kr
Korea, Republic of
 
NCT01643824
NCCCTS-12-622
No
Tae Hyun Kim, National Cancer Center, Korea
National Cancer Center, Korea
Not Provided
Principal Investigator: Tae Hyun Kim, Ph.D National Cancer Center, Korea
National Cancer Center, Korea
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP