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

Chinese Academy of Medical Sciences76 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Cancer

Interventions

postoperative radiotherapyRADIATION

IMRT or 3DCRT, 50-60Gy to the tumor bed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

overall survival

the rate of overall survival for 3 year

Time frame: 3 year

Secondary Outcomes

local recurrence free survival

the rate of local recurrence free survival for 3 years

Time frame: 3 years

disease free survival

the rate of disease free survival for 3 years

Time frame: 3 years

Number of Participants with Adverse Events

Time frame: 3 years

Data from ClinicalTrials.gov

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