Radiotherapy as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (RT-RFA)
November 17, 2008 updated by: Sun Yat-sen University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
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
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
-
Contact:
- min-shan chen, doctor
- Phone Number: 86-20-87343117 86-20-87343117
- Email: Chminsh@mail.sysu.edu.cn
-
Principal Investigator:
- min-shan chen, doctor
-
-
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:
- 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
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
RFA alone
|
radiofrequency ablation
|
|
Experimental: 1
radiotherapy after RFA
|
radiotherapy after RFA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survivals
Time Frame: 3, abd 5-years
|
3, abd 5-years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Recurrence rates
Time Frame: 3-, and 5-years
|
3-, and 5-years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: min-shan chen, doctor, Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
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
- 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.
- 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.
- 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.
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
November 1, 2007
Primary Completion (Anticipated)
November 1, 2009
Study Completion (Anticipated)
July 1, 2010
Study Registration Dates
First Submitted
November 9, 2007
First Submitted That Met QC Criteria
November 9, 2007
First Posted (Estimate)
November 12, 2007
Study Record Updates
Last Update Posted (Estimate)
November 18, 2008
Last Update Submitted That Met QC Criteria
November 17, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rfa-004
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