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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456156

Enrollment

Registered

2011-10-20

Start date

2008-01-31

Completion date

2017-01-31

Last updated

2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Cancer

Keywords

hepatocellular carcinoma, postoperative radiotherapy

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.

Interventions

RADIATIONpostoperative radiotherapy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
overall survival	3 year	the rate of overall survival for 3 year

Secondary

Measure	Time frame	Description
local recurrence free survival	3 years	the rate of local recurrence free survival for 3 years
disease free survival	3 years	the rate of disease free survival for 3 years
Number of Participants with Adverse Events	3 years	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026