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

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ClinicalTrials.gov Identifier: NCT01456156
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Tao Zhang, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Cancer Radiation: postoperative radiotherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
Actual Study Start Date : January 2008
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: hepatectomy plus radiotherapy Radiation: postoperative radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed
Other Name: adjuvant radiotherapy




Primary Outcome Measures :
  1. overall survival [ Time Frame: 3 year ]
    the rate of overall survival for 3 year


Secondary Outcome Measures :
  1. local recurrence free survival [ Time Frame: 3 years ]
    the rate of local recurrence free survival for 3 years

  2. disease free survival [ Time Frame: 3 years ]
    the rate of disease free survival for 3 years

  3. Number of Participants with Adverse Events [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456156


Locations
China, Beijing
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences

Responsible Party: Tao Zhang, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01456156     History of Changes
Other Study ID Numbers: CH-GI-019
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: July 2017

Keywords provided by Tao Zhang, Chinese Academy of Medical Sciences:
hepatocellular carcinoma
postoperative radiotherapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases