Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis (RHCC)

January 23, 2016 updated by: TaoBai, Guangxi Medical University
Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Recruiting
        • TaoBai
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with HCC at the Affiliated Tumor Hospital of Guangxi Medical University Science were considered for enrollment in the study. The diagnostic criteria for HCC used in the study were in accordance with the American Association for the Study of Liver Diseases' 2005 guidelines. All patients had preoperative serum a-fetoprotein (AFP) levels >200 ng/mL or a typical enhancement pattern (arterial enhancement and portal/delayed washed out) on dynamic imaging of hepatic mass(es)>2 cm, or cytologic/histologic evidence of HCC

Description

Inclusion Criteria:

  • HCC with no preoperative RT
  • resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function
  • compensated cirrhosis or no cirrhosis; Child-Pugh A
  • ECOG Performance Status of 0 or 1.
  • Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry

Exclusion Criteria:

  • unresectable hepatocellular carcinoma patients
  • Hepatocellular carcinoma without portal vein tumor thrombus
  • Hepatectomy without narrow margin(more than 1cm)
  • presence of distant metastasis
  • palliative resection with tumor residual
  • non-HCC confirmed by postoperative pathology

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

Cohorts and Interventions

Group / Cohort
RT
Resectable HCC patients adjuvant RT for PVT or NM
No RT
Resectable HCC patients adjuvant other treatment for PVT or NM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 1year
1year

Collaborators and Investigators

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

Sponsor

Guangxi Medical University

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 23, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAOBAI

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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