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

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Completed

Conditions

Hepatocellular Cancer

Treatments

Radiation: postoperative radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01456156
CH-GI-019

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

76 participants in 1 patient group

hepatectomy plus radiotherapy
Experimental group
Treatment:
Radiation: postoperative radiotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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