A Phase II Study of Radiotherapy for Locally Advanced Hepatocellular Carcinoma (HCC)

NCT00154817 | Completed Phase 2

• 1 other identifier: 910704
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.This is a phase II study of radiotherapy for patients with locally advanced HCC.
2. 2.Patients whose tumor(s) are not suitable for other local treatment, such as surgery, trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation. will be enrolled.
3. 3.Radical radiotherapy will be started after pre-treatment evaluation. The total dose of RT will be 50Gy in 25 fractions to local tumor(s).
4. 4.Dynamic contrast enhanced MRI and serum samples will be done at the following time points to assess the change in tumor perfusion: (1) before the start of thalidomide treatment; (2) 2weeks after radiotherapy begins; and (3) 1 month after radiotherapy completes. DCEMRI will then be done every 3 months until disease progression.
5. 5.The study was designed to evaluate the response rate and tolerability of radical radiotherapy for locally advanced HCC. The sample size was determined by the expected incidence of grade 4 toxicity and response rate of radiotherapy for locally advanced HCC. Since the grade 4 toxicity of radiotherapy alone is 10%, the response rate is 60% we need at least 12 patients to evaluate for the treatment.

Conditions

Hepatocellular Carcinoma

Keywords

radiotherapy; dynamic contrast enhanced MRI; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate response rate, tolerability and failure pattern of local radiotherapy for the treatment of locally advanced HCC.

Secondary Outcomes (1)

• The second objective is to correlate parameters of tumor perfusion assessed by dynamic contrast enhanced MRI (DCEMRI) and serum cytokine levels with clinical outcomes.

Interventions

radiotherapy PROCEDURE

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with measurable, locally advanced HCC that are not suitable for other local therapies, including surgery, TAE, alcohol injection, or radiofrequency ablation.
• 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.
• A persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.
• 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.
• Female patients in child-bearing age must have negative pregnancy test.

You may not qualify if:

• 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).
• Patients who have major systemic diseases that the attending physicians consider inappropriate for radiotherapy or thalidomide therapy.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hui-Ju Ch'ang, M.D.

  National Health Research Institutes, Division of Cancer Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2002
• Study Completion: May 1, 2005
• Last Updated: November 22, 2005

Record last verified: 2002-01