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

NCT00154817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2005-11-22

No results posted yet for this study

Summary

1. This is a phase II study of radiotherapy for patients with locally advanced HCC.
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. 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. 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. 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

Interventions

PROCEDURE

radiotherapy

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Hui-Ju Ch'ang, M.D. · National Health Research Institutes, Division of Cancer Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2005-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00154817 on ClinicalTrials.gov