search
Back to results

Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (RT-RFA)

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
RFA
radiotherapy after RFA
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, liver cancer, radiofrequency ablation, radiotherapy, adjuvant therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 - 75 years, who refused surgery
  • A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter
  • Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US,
  • No extrahepatic metastasis
  • No imaging evidence of invasion into the major portal/hepatic vein branches
  • No history of encephalopathy, ascites refractory to diuretics or variceal bleeding
  • A platelet count of > 40,000/mm3
  • No previous treatment of HCC except liver resection.

Exclusion Criteria:

  • Patient compliance is poor
  • The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted.
  • History of cardiac disease:

    • congestive heart failure > New York Heart Association (NYHA) class 2;
    • active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted);
    • cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or
    • uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs).
  • Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • Distantly extrahepatic metastasis
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Known or suspected allergy to the investigational agent or any agent given in association with this trial
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Excluded therapies and medications, previous and concomitant:

    • Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization.
    • Prior use of systemic investigational agents for HCC
    • Autologous bone marrow transplant or stem cell rescue within four months of start of study drug

Sites / Locations

  • Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

radiotherapy after RFA

RFA alone

Outcomes

Primary Outcome Measures

Overall survivals

Secondary Outcome Measures

Recurrence rates

Full Information

First Posted
November 9, 2007
Last Updated
November 17, 2008
Sponsor
Sun Yat-sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT00557024
Brief Title
Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Acronym
RT-RFA
Official Title
Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the investigators study is to prospectively evaluate whether radiotherapy as an adjuvant therapy after RFA will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC) or not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver Cancer
Keywords
hepatocellular carcinoma, liver cancer, radiofrequency ablation, radiotherapy, adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
radiotherapy after RFA
Arm Title
2
Arm Type
Active Comparator
Arm Description
RFA alone
Intervention Type
Procedure
Intervention Name(s)
RFA
Intervention Description
radiofrequency ablation
Intervention Type
Procedure
Intervention Name(s)
radiotherapy after RFA
Other Intervention Name(s)
RT-RFA
Intervention Description
radiotherapy after RFA
Primary Outcome Measure Information:
Title
Overall survivals
Time Frame
3, abd 5-years
Secondary Outcome Measure Information:
Title
Recurrence rates
Time Frame
3-, and 5-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: Age 18 - 75 years, who refused surgery A solitary HCC ≤ 7.0cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0cm in diameter Lesions being visible on ultrasound (US) and with an acceptable/safe path between the lesion and the skin as shown on US, No extrahepatic metastasis No imaging evidence of invasion into the major portal/hepatic vein branches No history of encephalopathy, ascites refractory to diuretics or variceal bleeding A platelet count of > 40,000/mm3 No previous treatment of HCC except liver resection. Exclusion Criteria: Patient compliance is poor The blood supply of tumor lesions is absolutely poor or arterial-venous shunt that TACE can not be performed Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted. History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is permitted); cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blocker or digoxin; or uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of 3 antihypertensive drugs). Active clinically serious infections ( > grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) Known history of human immunodeficiency virus (HIV) infection Known Central Nervous System tumors including metastatic brain disease Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry Distantly extrahepatic metastasis History of organ allograft Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Known or suspected allergy to the investigational agent or any agent given in association with this trial Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial. Excluded therapies and medications, previous and concomitant: Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior randomization. Prior use of systemic investigational agents for HCC Autologous bone marrow transplant or stem cell rescue within four months of start of study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
min-shan chen, doctor
Phone
86-20-87343117
Ext
86-20-87343117
Email
Chminsh@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
min-shan chen, doctor
Organizational Affiliation
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
min-shan chen, doctor
Phone
86-20-87343117
Ext
86-20-87343117
Email
Chminsh@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
min-shan chen, doctor

12. IPD Sharing Statement

Citations:
PubMed Identifier
11923602
Citation
Poon RT, Fan ST, Tsang FH, Wong J. Locoregional therapies for hepatocellular carcinoma: a critical review from the surgeon's perspective. Ann Surg. 2002 Apr;235(4):466-86. doi: 10.1097/00000658-200204000-00004.
Results Reference
background
PubMed Identifier
16495695
Citation
Chen MS, Li JQ, Zheng Y, Guo RP, Liang HH, Zhang YQ, Lin XJ, Lau WY. A prospective randomized trial comparing percutaneous local ablative therapy and partial hepatectomy for small hepatocellular carcinoma. Ann Surg. 2006 Mar;243(3):321-8. doi: 10.1097/01.sla.0000201480.65519.b8.
Results Reference
background
PubMed Identifier
11419162
Citation
Buscarini L, Buscarini E, Di Stasi M, Vallisa D, Quaretti P, Rocca A. Percutaneous radiofrequency ablation of small hepatocellular carcinoma: long-term results. Eur Radiol. 2001;11(6):914-21. doi: 10.1007/s003300000659.
Results Reference
background

Learn more about this trial

Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

We'll reach out to this number within 24 hrs