Dose Escalation Study Using Respiratory Gated Proton Beam Radiotherapy for Hepatocellular Carcinoma - Full Text View

Sponsored by:	National Cancer Center, Korea
Information provided by:	National Cancer Center, Korea
ClinicalTrials.gov Identifier:	NCT00662246

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase I Dose Escalation Study Using Respiratory Gated Proton Beam Radiotherapy for Hepatocellular Carcinoma

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 ]

Estimated Enrollment:	48
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Primary objectives : To establish the maximum tolerable dose by evaluating the acute radiation radiation-induced hepatic toxicity in hepatocellular carcinoma (HCC) patients treated with proton beam radiotherapy	Radiation: respiratory gated proton beam radiotherapy - Prescription dose to PTV as according to the following dose escalation schema: Group 1: Tumor size ≤5cm 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. Group 2: 5cm <Tumor size ≤10cm Dose level 1: 54 GyE /18 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 66 GyE /22 fx, 3GyE fraction dose, 5 days/week.

Arms

Assigned Interventions

1: Experimental

Primary objectives :

To establish the maximum tolerable dose by evaluating the acute radiation radiation-induced hepatic toxicity in hepatocellular carcinoma (HCC) patients treated with proton beam radiotherapy

Radiation: respiratory gated proton beam radiotherapy

- Prescription dose to PTV as according to the following dose escalation schema:

Group 1: Tumor size ≤5cm 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.
Group 2: 5cm <Tumor size ≤10cm Dose level 1: 54 GyE /18 fx, 3GyE fraction dose, 5 days/week. Dose level 2: 60 GyE /20 fx, 3GyE fraction dose, 5 days/week. Dose level 3: 66 GyE /22 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662246

Contacts

Contact: Tae Hyun Kim

82-31-920-0155

krog@ncc.re.kr

Locations

Korea, Republic of, Gyeonggi
National Cancer Center Korea	Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Tae Hyun Kim 82-31-920-0155 krog@ncc.re.kr

Sponsors and Collaborators

National Cancer Center, Korea

More Information

Responsible Party:	National Cancer Center Korea ( Tae Hyun Kim )
Study ID Numbers:	NCCCTS-07-225
Study First Received:	April 10, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00662246
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009