Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

NCT00155272 | Unknown Phase 1

• 1 other identifier: 931003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 serum cytokines will be evaluated.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Radiotherapy; Thalidomide; Dynamic contrast enhanced MRI

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 20 Years - 70 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 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.
• 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

Study Sites (1)

NTUH

Taipei, 100, Taiwan

RECRUITING

Related Publications (2)

• Liang PC, Ch'ang HJ, Hsu C, Chen LT, Shih TT, Liu TW. Perfusion parameters of dynamic contrast-enhanced magnetic resonance imaging predict outcomes of hepatocellular carcinoma receiving radiotherapy with or without thalidomide. Hepatol Int. 2015 Apr;9(2):258-68. doi: 10.1007/s12072-014-9557-1. Epub 2014 Jul 26.

  PMID: 25788178 DERIVED

• Ch'ang HJ, Hsu C, Chen CH, Chang YH, Chang JS, Chen LT. Phase II study of concomitant thalidomide during radiotherapy for hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):817-25. doi: 10.1016/j.ijrobp.2010.10.067. Epub 2011 Jan 27.

  PMID: 21277098 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Thalidomide

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hui-Ju Ch'ang, M.D.

  National Health Research Institutes, Division of Cancer Research

  PRINCIPAL INVESTIGATOR

• Chih-Hung Hsu, M.D.

  National Taiwan University Hospital

  STUDY CHAIR

• Tiffany Ting Fang Shih, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chieh Yu, R.N.

CONTACT

23123456; ntuhccw@nhri.org.tw

Hui-Ju Ch'ang, M.D.

CONTACT

23123456; hjmc@nhri.org.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: March 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 12, 2005

Record last verified: 2005-08

Locations

TW (1)