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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

October 12, 2011
October 20, 2011
July 5, 2017
January 2008
January 2017   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: 3 year ]
the rate of overall survival for 3 year
Same as current
Complete list of historical versions of study NCT01456156 on ClinicalTrials.gov Archive Site
  • local recurrence free survival [ Time Frame: 3 years ]
    the rate of local recurrence free survival for 3 years
  • disease free survival [ Time Frame: 3 years ]
    the rate of disease free survival for 3 years
  • Number of Participants with Adverse Events [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
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
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hepatocellular Cancer
Radiation: postoperative radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed
Other Name: adjuvant radiotherapy
Experimental: hepatectomy plus radiotherapy
Intervention: Radiation: postoperative radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
Same as current
January 2017
January 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01456156
CH-GI-019
No
Not Provided
Not Provided
Tao Zhang, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Not Provided
Not Provided
Chinese Academy of Medical Sciences
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP