Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Conditions
Hepatocellular Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
hepatocellular carcinoma, postoperative radiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: postoperative radiotherapy
Type: Radiation
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
Location
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China
Status: Recruiting
Start Date
January 2008
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page