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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hepatectomy plus radiotherapy

Group Type EXPERIMENTAL

postoperative radiotherapy

Intervention Type RADIATION

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

Interventions

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postoperative radiotherapy

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

Intervention Type RADIATION

Other Intervention Names

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adjuvant radiotherapy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No