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Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by Tae Hyun Kim, National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Tae Hyun Kim, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT02395523
First received: March 17, 2015
Last updated: October 5, 2015
Last verified: October 2015
  Purpose
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for Hepatocellular Carcinoma patients in hepatitis B endemic area.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Inoperable Hepatocellular Carcinoma

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

Primary Outcome Measures:
  • local progression - free survival [ Time Frame: Up to 1 year ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: Up to 2 years until study closed ]

Estimated Enrollment: 45
Study Start Date: March 2015
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Beam Therapy

Definition of target volume:

  • Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan
  • Clinical target volume (CTV) = GTV + internal target volume
  • Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins.

Radiation dose and planning

  • Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week
  • Dose prescription : 95% isodose volume of prescribed dose encompassed PTV
Radiation: Proton Beam Therapy

Definition of target volume:

  • Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan
  • Clinical target volume (CTV) = GTV + internal target volume
  • Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins.

Radiation dose and planning

  • Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week
  • 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 will be enrolled.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hepatocellular Carcinoma 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
  • Inoperable HCC or refusal to surgery
  • Recurrent/residual tumor after other local treatments (local ablation therapy, or transarterial chemoemobolization, etc), or unsuitable/refusal to other treatments.
  • Patients without evidence of extrahepatic metastasis
  • The largest diameter of tumor should be less than 7cm, and the number of tumor ≤2
  • The targeted tumors is more than 2cm away from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel)
  • 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 1 on the Eastern Cooperative Oncology Group (ECOG) score
  • Required Entry Laboratory Parameters WBC count ≥ 1,500/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 30,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT < 5.0× upper limit of normal; no uncontrolled ascites
  • No serious comorbidities other than liver cirrhosis
  • Signed informed consent form prior to study entry

Exclusion Criteria:

  • There is evidence of extrahepatic metastasis.
  • Age of <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 2 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
  • Multicentric HCCs, except for those with the following two conditions: (i) multinodular aggregating HCC that could be encompassed by single clinical target volume and within single clinical target volume; (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
  • Pregnant or breast feeding status
  • Previous history uncontrolled other malignancies within 2 years
  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: NCT02395523

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         
Sub-Investigator: Ju Hee Lee, Ph.D         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Tae Hyun Kim, Ph.D National Cancer Center, Korea
  More Information

Responsible Party: Tae Hyun Kim, Principal investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02395523     History of Changes
Other Study ID Numbers: NCCCTS-15-042
Study First Received: March 17, 2015
Last Updated: October 5, 2015

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases

ClinicalTrials.gov processed this record on September 21, 2017