Status:
UNKNOWN
Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Health Research Institutes, Taiwan
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally advanced HCC.Besides toxicity and efficacy, mechanistic studies including dynamic contrast enhanced MRI and ...
Detailed Description
This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally advanced HCC. Patients whose tumor(s) are not suitable for other local treatment, such as surgery, trans-art...
Eligibility Criteria
Inclusion
- 1 Patients with measurable, locally advanced HCC that are not suitable for other local therapies, including surgery, TAE, alcohol injection, or radiofrequency ablation.
- 2 Patients with histological confirmed HCC or patients who do not have histological diagnosis but have met all of the following criteria: 1.2.1 Presence of chronic viral hepatitis and/or cirrhosis 1.2.2 Presence of hepatic tumor(s) with image findings (sonography, CT scan) compatible with HCC.
- 2.3 A persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.
- 3 Patients without any local or systemic therapy for HCC within 4 weeks. 1.4 Patients with age \> 20 years and \< 70 years. 1.5 Patients with a performance status of ECOG score \< 1. 1.6 Patients must fulfill all of the following criteria: 1.6.1 Child-Pugh's Score ≦ 7. 1.6.2 Serum total bilirubin \< 1.5 times upper normal limit (UNL 1.6.3 Serum alanine transaminase (ALT) \< 5 times UNL 1.6.4 Platelet count \> 5.0 x 104 / mm3. 1.6.5 White blood cell count \> 3,000 / mm3. 1.6.6 Serum creatinine \< 2.0 mg/dL 1.7 Patient must have local tumors less than one half of the whole liver and the tumors can be encompassed within RT fields 1.8 Signed informed consent 1.9 Sexually active patients, in conjunction with their partner, must practice birth control during, and for 2 months after, thalidomide therapy.
- 10 Female patients in child-bearing age must have negative pregnancy test.
Exclusion
- 1. Patients with documented extrahepatic metastasis. 2.2. Patients who received previous radiotherapy to abdominal area. 2.3. Patients who have received thalidomide treatment prior to enrollment. 2.4. Patients who had other investigational drug treatment within 4 weeks prior to enrollment.
- 5. Patients with NCI grade 2 or greater peripheral neuropathy of any causes. 2.6. Patients with other systemic diseases that required concurrent usage of glucocorticosteroid or immunosuppressant agent(s).
- 7. Patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00155272
Start Date
March 1 2005
End Date
August 1 2005
Last Update
September 12 2005
Active Locations (1)
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1
NTUH
Taipei, Taiwan, 100