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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatocellular Cancer

Intervention / Treatment
-----------------
* Radiation: postoperative radiotherapy


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hepatectomy plus radiotherapy<br> | Radiation: postoperative radiotherapy<br>* IMRT or 3DCRT, 50-60Gy to the tumor bed<br>* Other names: adjuvant radiotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | the rate of overall survival for 3 year | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence free survival | the rate of local recurrence free survival for 3 years | 3 years | 
| disease free survival | the rate of disease free survival for 3 years | 3 years | 
| Number of Participants with Adverse Events |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatocellular carcinoma, postoperative radiotherapy