Back to results

Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

respiratory gated proton beam radiotherapy

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cancer Center Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT00662246

First Posted

April 10, 2008

Last Updated

April 2, 2012

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00662246

Brief Title

Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

Official Title

A Phase I Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

respiratory gated proton beam radiotherapy

Intervention Description

- 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.

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

National Cancer Center Korea

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-769

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Dose Escalation Study Using Proton Beam Radiotherapy for Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs