Status:
COMPLETED
Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00662246
Start Date
January 1 2007
End Date
March 1 2010
Last Update
April 3 2012
Active Locations (1)
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1
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769