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| Sponsors and Collaborators: |
National Taiwan University Hospital National Health Research Institutes, Taiwan |
|---|---|
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00155272 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Thalidomide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma |
| Estimated Enrollment: | 19 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
2.5. 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.
Contacts and Locations| Contact: Yu-Chieh Yu, R.N. | 23123456 ext 7658 | ntuhccw@nhri.org.tw |
| Contact: Hui-Ju Ch'ang, M.D. | 23123456 ext 2959 | hjmc@nhri.org.tw |
| Taiwan | |
| NTUH | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Hui-Ju Ch'ang, M.D. 23123456 ext 2959 hjmc@nhri.org.tw | |
| Principal Investigator: Hui-Ju Ch'ang, M.D. | |
| 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 |
More Information
| Study ID Numbers: | 931003 |
| Study First Received: | September 8, 2005 |
| Last Updated: | September 8, 2005 |
| ClinicalTrials.gov Identifier: | NCT00155272 History of Changes |
| Health Authority: | Taiwan: Department of Health |
|
Hepatocellular Carcinoma Radiotherapy Thalidomide Dynamic contrast enhanced MRI |
|
Liver Diseases Digestive System Neoplasms Thalidomide Immunologic Factors Carcinoma, Hepatocellular Angiogenesis Inhibitors Immunosuppressive Agents Carcinoma |
Liver Neoplasms Anti-Bacterial Agents Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
|
Anti-Infective Agents Liver Diseases Thalidomide Immunologic Factors Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Liver Neoplasms Anti-Bacterial Agents Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |
Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Leprostatic Agents |
