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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01456156
Other study ID # CH-GI-019
Secondary ID
Status Completed
Phase N/A
First received October 12, 2011
Last updated July 2, 2017
Start date January 2008
Est. completion date January 2017

Study information

Verified date July 2017
Source Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hepatectomy is difficult when the tumor is adjacent to the big vessels of the liver and some patients can not receive radical resection. Such patients have high risk of recurrence. Tumor resection and postoperative radiation is an option for such patients to achieve radical treatment and radiation may reduce local recurrence.


Description:

Patients with risk factors of recurrence receive postoperative radiotherapy using intensive modulated radiation therapy (IMRT) or three-dimensional conformal radiation therapy (3DCRT). The clinical target volume includes tumor bed. The dose will be 50-60Gy/25-30f. Overall survival, local-recurrence free survival, disease free survival and toxicity need be observed.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- written informed consent provided

- 18~75 years old

- patients with histopathological proved hepatocellular carcinoma received hepatectomy and had at least one risk factor of recurrence

- without any lymph node or distant metastasis (any T N0M0)

- liver function: Child-Pugh A or B

- Performance status: Karnofsky (KPS)=70 or world health organization(WHO) score 0,1

- life expectation>6 months

- no dysfunction of major organs

- no prior radiotherapy

- negative for human immunodeficiency virus syndrome (HIV)

- Considerable to computed tomography(CT) simulation and 3D-CRT or IMRT

Exclusion Criteria:

- malignant tumors of other sits

- combining severe diseases, such as acute myocardial infarction(AMI), arrhythmias, infection

- surgery performed in other hospitals without details

- pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)

Study Design


Intervention

Radiation:
postoperative radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed

Locations

Country Name City State
China Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival the rate of overall survival for 3 year 3 year
Secondary local recurrence free survival the rate of local recurrence free survival for 3 years 3 years
Secondary disease free survival the rate of disease free survival for 3 years 3 years
Secondary Number of Participants with Adverse Events 3 years
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