Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

NCT ID: NCT00155272

Last Updated: 2005-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2005-08-31

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.

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Radiotherapy; Thalidomide; Dynamic contrast enhanced MRI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Thalidomide

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Hui-Ju Ch'ang, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Division of Cancer Research

Chih-Hung Hsu, M.D.

Role: STUDY_CHAIR

National Taiwan University Hospital

Tiffany Ting Fang Shih, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

NTUH

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Chieh Yu, R.N.

Role: CONTACT

Phone: 23123456

Email: ntuhccw@nhri.org.tw

Hui-Ju Ch'ang, M.D.

Role: CONTACT

Phone: 23123456

Email: hjmc@nhri.org.tw

Facility Contacts

Hui-Ju Ch'ang, M.D.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 25788178 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21277098 (View on PubMed)

Other Identifiers

931003

Identifier Type: -

Identifier Source: org_study_id