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
  Purpose

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


Condition Intervention Phase
Hepatocellular Carcinoma
Radiation: Proton Beam Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 135
Study Start Date: June 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Therapy 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643824

Contacts
Contact: Tae Hyun Kim, Ph.D +82-31-920-1725 k2onco@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-769
Contact: Tae Hyun Kim, Ph.D    +82-31-920-1725    k2onco@ncc.re.kr   
Sub-Investigator: Joong Won Park, Ph.D         
Sub-Investigator: Chang Min Kim, Ph.D         
Sub-Investigator: Bo Hyun Kim, Ph.D         
Sub-Investigator: Young Hwan Koh, Ph.D         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Tae Hyun Kim, Ph.D National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Tae Hyun Kim, Principal investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01643824     History of Changes
Other Study ID Numbers: NCCCTS-12-622
Study First Received: July 12, 2012
Last Updated: May 26, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014