Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

July 24, 2018 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study

The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Study Type

Interventional

Enrollment (Anticipated)

110

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
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years old and above.
  2. Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
  3. Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis
  4. No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency
  5. The neutrophil count is at least 1.0*10^9/ml, and the platelet count is at least 50*10^9/ml. Hemoglobin is at least 80g/L.
  6. Men or women with fertility are willing to take contraceptive measures during the trial
  7. Eastern Cooperative Oncology Group score 0-1 points
  8. Expected survival period > 3 months
  9. Voluntary participation and signing of informed consent

Exclusion Criteria:

  1. Patients who have undergone chemoradiation or targeted therapy for liver cancer
  2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points
  3. Total bilirubin >70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
  4. Patients undergoing major surgery within 1 month of study initiation
  5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
  6. Researchers consider it inappropriate to participate in the test

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MWA
Patients receive microwave ablation (MWA)
Device: microwave ablation (MWA)
microwave ablation (MWA) for recurrent small liver cancer
EXPERIMENTAL: SBRT
Patients receive stereotactic body radiotherapy (SBRT)
Radiation: stereotactic body radiotherapy (SBRT)
stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.
Progression-free survival (PFS) was measured from the date of MWA or the first fraction of SBRT until the date of first progression (local or distant).
From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
local recurrence free survival
Time Frame: From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
Local recurrence free survival (LRFS) was measured from the date of MWA or the first fraction of SBRT until the date of local recurrence.
From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
overall survival
Time Frame: From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years
Overall survival (OS) was measured from the date of MWA or the first fraction of SBRT until the date of death.
From the date of MWA or the first fraction of SBRT until the date of death, assessed up to 3 years

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang 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 (ACTUAL)

June 30, 2018

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

May 31, 2021

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (ACTUAL)

August 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 24, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR2018001025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Recurrent Hepatocellular Carcinoma

Clinical Trials on microwave ablation (MWA)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe