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

July 2, 2017 updated by: Tao Zhang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hepatectomy plus radiotherapy
Radiation: postoperative radiotherapy
IMRT or 3DCRT, 50-60Gy to the tumor bed
Other Names:
  • adjuvant radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 3 year
the rate of overall survival for 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: 3 years
3 years
local recurrence free survival
Time Frame: 3 years
the rate of local recurrence free survival for 3 years
3 years
disease free survival
Time Frame: 3 years
the rate of disease free survival for 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 12, 2011

First Submitted That Met QC Criteria

October 18, 2011

First Posted (Estimate)

October 20, 2011

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

July 2, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CH-GI-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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