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

Hepatocellular Cancer Clinical Trial

Official title:

Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456156
• Other study ID #: CH-GI-019
• 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
• 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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Cancer
• Liver Neoplasms

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