Study of Stereotactic Body Radiotherapy for Hepatocellular Carcinoma/Metastatic Liver Tumors

JRCT ID: jRCT1030220731

Registered date:25/03/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: hepatocellular carcinoma, liver neoplasms
• Date of first enrollment: 25/03/2023
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Stereotactic body radiotherapy for hepatocellular carcinoma or liver metastatic tumors.
The total dose is 50 / 60 / 70 Gy in 10 fractions once a day.
We start with the lowest dose level and gradually increase the dose level while assessing safety.

Outcome(s)

• Primary Outcome: Incidence rate of Grade 3 oredr higher adverse events that occurred within 90 days after the end of radiation therapy (evaluated by Common terminology Criteria for Adverse Events: CTCAE version 5.0)

Secondary Outcome

1.Incidence of any adverse events within 90 days of completion of radiotherapy (as assessed by CTCAE version 5.0 JCOG)
2.Incidence of adverse events occurring after 91 days of radiotherapy (as assessed by CTCAE version 5.0 JCOG)
3.Incidence rate of adverse events based on subjective evaluation (Patient-Reported Outcome Common Terminology Criteria for Adverse Events: PRO-CTCAE version 1.0 JCOG version)
4.Overall Survival
5.Local recurrence-free survival: Date of recurrence is the date on which dynamic CT or EOB-MRI of the liver again confirms an increase in the treated lesion or a contrast-enhancing lesion in the irradiated field.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

a) Patients with pathologically or clinically (by dynamic contrast-enhanced CT or EOB-MRI of the liver) diagnosed primary or recurrent hepatocellular carcinoma or localized metastatic liver tumor who are not candidates for radical treatment (liver resection, RFA, liver transplantation) and will receive stereotactic body radiation therapy.
b) Patients whose pre-enrollment treatment plan meets the dose constraints".
c) Patients with Child-pugh classification grade A or B.
d) Performance status (PS) of 0-2.
e) Over 18 years old.
f) Patients who have given their written consent to participate in the study.

Exclude criteria

a) Patients who do not consent to participate in the study.
b) With lymph node metastasis or distant metastasis in other organs.
c) With a history of prior radiotherapy to liver.
d) With WBC <2,000/mm3, HB <8g/dl, or Plt <50.000/mm3.
e) Patients participating in other clinical trials that may affect the conduct or outcome of this study.
f) Other patients who are deemed inappropriate to participate in this study by the investigator or co-investigaters.

Related Information

• Primary Sponsor: Yamashita Hideomi