Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

September 8, 2005 updated by: National Taiwan University Hospital

A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

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 serum cytokines will be evaluated.

Study Overview

Status

Unknown

Conditions

Hepatocellular Carcinoma

Intervention / Treatment

Drug: Thalidomide

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-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation. will be enrolled.Radical radiotherapy will be started after pre-treatment evaluation. The total dose of RT will be 50Gy in 25 fractions to local tumor(s). Oral Thalidomide will be started 3 days before RT begins. Thalidomide treatment will continue for totally 6 months or until tumor progression. Dynamic contrast enhanced MRI (DCEMRI) will be done at the following time points to assess the change in tumor perfusion: (1) before the start of thalidomide treatment; (2) 3 days after thalidomide before radiotherapy; (3) 2weeks after radiotherapy begins;and (4) 1 month after radiotherapy completes. DCEMRI will then be done every 3 months until disease progression.Serum samples for angiogenic cytokine studies will also be collected.The study was designed to evaluate the feasibility and tolerability of combination treatment of radiotherapy and thalidomide for locally advanced HCC. The sample size was determined by the expected incidence of grade 4 toxicity of the combination treatment versus radiotherapy alone for locally advanced HCC. Since the grade 4 toxicity of radiotherapy alone is 7-9%, we need at least 15 patients to evaluate for feasibility of the combination treatment. With an estimated drop out rate of approximately 10%, 17 patients will be enrolled.

Study Type

Interventional

Enrollment

Phase

Phase 2
Phase 1

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

Taiwan
- - Taipei, Taiwan, 100
    - Recruiting
    - NTUH
    - Contact:
      
      Hui-Ju Ch'ang, M.D.
      
      Phone Number: 2959 23123456
      
      Email: hjmc@nhri.org.tw
    - Principal Investigator:
      
      Hui-Ju Ch'ang, M.D.

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.1 Patients with measurable, locally advanced HCC that are not suitable for other local therapies, including surgery, TAE, alcohol injection, or radiofrequency ablation.

1.2 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.

1.2.3 A persistent elevation of serum a-fetoprotein level ³ 400 ng/ml without any evidence of ana-fetoprotein-secreting germ cell tumor.

1.3 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.

1.10 Female patients in child-bearing age must have negative pregnancy test.

Exclusion Criteria:

2.1. 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.

2.5. 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).

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

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: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint is the feasibility and tolerability of thalidomide plus radiotherapy.

Secondary Outcome Measures

Outcome Measure
The secondary end point is correlation of parameters of tumor perfusion assessed by DCEMRI and serum cytokine levels with objective tumor response.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Health Research Institutes, Taiwan

Investigators

Principal Investigator: Hui-Ju Ch'ang, M.D., National Health Research Institutes, Division of Cancer Research
Study Chair: Chih-Hung Hsu, M.D., National Taiwan University Hospital
Principal Investigator: Tiffany Ting Fang Shih, M.D., National Taiwan University Hospital

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

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

March 1, 2005

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 12, 2005

Last Update Submitted That Met QC Criteria

September 8, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

931003

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