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

Sponsor
Chinese Academy of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01456156
Collaborator
(none)
76
Enrollment
1
Location
1
Arm
108
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: postoperative radiotherapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
N/A
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 :
Jan 1, 2008
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: hepatectomy plus radiotherapy

Radiation: postoperative radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed
Other Names:
  • adjuvant radiotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [3 year]

      the rate of overall survival for 3 year

    Secondary Outcome Measures

    1. local recurrence free survival [3 years]

      the rate of local recurrence free survival for 3 years

    2. disease free survival [3 years]

      the rate of disease free survival for 3 years

    3. Number of Participants with Adverse Events [3 years]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021

    Sponsors and Collaborators

    • Chinese Academy of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tao Zhang, Principal Investigator, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01456156
    Other Study ID Numbers:
    • CH-GI-019
    First Posted:
    Oct 20, 2011
    Last Update Posted:
    Jul 5, 2017
    Last Verified:
    Jul 1, 2017
    Keywords provided by Tao Zhang, Principal Investigator, Chinese Academy of Medical Sciences
    hepatocellular carcinoma
    postoperative radiotherapy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Liver Neoplasms

    Study Results

    No Results Posted as of Jul 5, 2017