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Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma (LDT-RFA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00728078
First received: July 31, 2008
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

The purpose of the investigators' study is to prospectively evaluate whether low-dose thalidomide adjuvant therapy will improve the outcome of radiofrequency ablation for hepatocellular carcinoma (HCC).


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
Drug: thalidomide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Low-Dose Thalidomide as Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • progress free survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
  • morbility [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]
  • recurrence rate [ Time Frame: 1,3,5-year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
low-dose thalidomide adjuvant therapy after RFA for HCC
Drug: thalidomide
thalidomide 50mg tid for 6 months
No Intervention: 2
control group

Detailed Description:

Our previous studies showed that radiofrequency ablation (RFA) was as effective as liver resection for small hepatocellular carcinoma (HCC), but the recurrence rates after RFA were relatively high. Adjuvant therapies maybe reduce the recurrence rate. Phase 1 and 2 studies showed that thalidomide was a safety and effective treatment for HCC, especially for small HCC with liver cirrhosis. So we proposed that low-dose thalidomide adjuvant therapy will improve the disease progress free survivals and overall survivals after RFA for HCC.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 - 75 years, who refused surgery or first recurrence after hepatectomy
  • A solitary HCC 3.1-7.0cm in diameter, or 2-3 lesions, sums of diameters ≤ 7.0cm
  • 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
  • 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
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728078

Contacts
Contact: min-shan chen, MD 86-20-87343117 ext 86-20-87343117 Chminsh@mail.sysu.edu.cn

Locations
China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: min-shan chen, MD    86-20-87343117 ext 86-20-87343117    Chminsh@mail.sysu.edu.cn   
Principal Investigator: min-shan chen, MD         
Sub-Investigator: yao-jun zhang, Doctor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: min-shan chen, MD Department of Hepatobilliary Surgery, Cancer Center, Sun Yat-sen University
  More Information

Publications:
Responsible Party: cancer canter, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00728078     History of Changes
Other Study ID Numbers: RFA005
Study First Received: July 31, 2008
Last Updated: February 6, 2009
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
hepatocellular carcinoma
liver cancer
radiofrequency ablation
thalidomide

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014