Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT00662246
First received: April 10, 2008
Last updated: April 2, 2012
Last verified: March 2012
  Purpose

The radical treatment for Hepatocellular carcinoma (HCC) is surgery. However, it is only for 10 to 20% of all patients and 10 to 30% of them have relapsed every year after surgery. For an inoperable case, we can consider Liver transplantation. But there is not enough organ donor and it is very expensive. In that case, various treatment modalities for HCC (i.e., transcatheter arterial embolization [TAE] and percutaneous ethanol injection [PEI], radiofrequency ablation etc.) have become clinically available. In addition, after these treatment, radiation therapy can be conducted as a combined treatment. If it is difficult, radiation therapy can be conducted alone. In this case, radiation therapy can use fractionated stereotactic radiation therapy [FSRT] or 3D simulation to minimize the exposure to normal tissues. In recent years, Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation. The purpose of this trial is to improve the therapeutic effects by using proton therapy.


Condition Intervention Phase
Carcinoma, Hepatocellular
Radiation: respiratory gated proton beam radiotherapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Primary objectives :

  • to determine the recommended dose (i.e., the safest and most effective dose) by evaluating frequency of patients developing unacceptable (grade 3 or higher) acute toxicities attributable to proton beam radiotherapy for HCC.
Radiation: respiratory gated proton beam radiotherapy
- Prescription dose to PTV as according to the following dose escalation schema: Dose level 1: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 72 GyE /24 fx, 3GyE fraction dose, 5 days/week.

  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 400 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms
    • (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 400 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 (12x12 cm maximum)
  • No previous treatment to target tumors by other forms of RT
  • Digestive tract not in contact with clinical target volume
  • Liver function of Child-Pugh class A or B
  • 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

Exclusion Criteria:

  • Evidence of extrahepatic metastasis
  • Age < 18 years
  • Liver function of Child-Pugh class C
  • 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
  • Diffusely infiltrating tumor which is difficult to define the gross tumor volume accurately
  • 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 irradiation field (15x15 cm maximum)
    • (ii) lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy
  • Digestive tract in contact with clinical target volume
  • 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: NCT00662246

Locations
Korea, Republic of
National Cancer Center Korea
Goyang, Gyeonggi, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Tae Hyun Kim, National Cancer Center Korea
ClinicalTrials.gov Identifier: NCT00662246     History of Changes
Other Study ID Numbers: NCCCTS-07-225
Study First Received: April 10, 2008
Last Updated: April 2, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014