Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma

Not Applicable

Completed

• Conditions: Hepatocellular Cancer
• Interventions: Radiation: postoperative radiotherapy

• Registration Number: NCT01456156
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-02
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hepatectomy plus radiotherapy	postoperative radiotherapy	-

Primary Outcome Measures

Name	Time	Method
overall survival	3 year	the rate of overall survival for 3 year

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	3 years
local recurrence free survival	3 years	the rate of local recurrence free survival for 3 years
disease free survival	3 years	the rate of disease free survival for 3 years

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China