search
Back to results

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

Primary Purpose

Hepatocellular Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
postoperative radiotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Cancer focused on measuring hepatocellular carcinoma, postoperative radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hepatectomy plus radiotherapy

Arm Description

Outcomes

Primary Outcome Measures

overall survival
the rate of overall survival for 3 year

Secondary Outcome Measures

local recurrence free survival
the rate of local recurrence free survival for 3 years
disease free survival
the rate of disease free survival for 3 years
Number of Participants with Adverse Events

Full Information

First Posted
October 12, 2011
Last Updated
July 2, 2017
Sponsor
Chinese Academy of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01456156
Brief Title
Study of Postoperative 3D-CRT/IMRT in Hepatocellular Carcinoma
Official Title
Phase 2 Study of Postoperative Three-dimensional Conformal Radiation Therapy/Intensive Modulated Radiation Therapy in Hepatocellular Carcinoma: a Single Center Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
Keywords
hepatocellular carcinoma, postoperative radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hepatectomy plus radiotherapy
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
postoperative radiotherapy
Other Intervention Name(s)
adjuvant radiotherapy
Intervention Description
IMRT or 3DCRT, 50-60Gy to the tumor bed
Primary Outcome Measure Information:
Title
overall survival
Description
the rate of overall survival for 3 year
Time Frame
3 year
Secondary Outcome Measure Information:
Title
local recurrence free survival
Description
the rate of local recurrence free survival for 3 years
Time Frame
3 years
Title
disease free survival
Description
the rate of disease free survival for 3 years
Time Frame
3 years
Title
Number of Participants with Adverse Events
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34097307
Citation
Chen B, Wu JX, Cheng SH, Wang LM, Rong WQ, Wu F, Wang SL, Jin J, Liu YP, Song YW, Ren H, Fang H, Tang Y, Li N, Li YX, Wang WH. Phase 2 Study of Adjuvant Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC. Hepatology. 2021 Nov;74(5):2595-2604. doi: 10.1002/hep.31993. Epub 2021 Sep 16.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs