Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

• Sponsor: National Cancer Center, Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT00662246
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 37.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Radiation: respiratory gated proton beam radiotherapy	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. all cause mortality [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Center Korea	Goyang	Gyeonggi	Korea, Republic of	410-769

Sponsors and Collaborators

• National Cancer Center, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00662246
• Other Study ID Numbers: NCCCTS-07-225
• First Posted: Apr 21, 2008
• Last Update Posted: Apr 3, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Apr 3, 2012