Spots Global Cancer Trial Database for Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

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

Study ID: NCT00155272

Conditions

Hepatocellular Carcinoma

Interventions

Thalidomide

Study Description

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.