Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155272
Status:
UNKNOWN
Last Update Posted:
2005-09-12
First Post:
2005-09-08
Brief Title:
Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally advanced HCCBesides 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 tumors are not suitable for other local treatment such as surgery trans-arterial chemoembolization TAE ethanol injection or radiofrequency ablation will be enrolledRadical radiotherapy will be started after pre-treatment evaluation The total dose of RT will be 50Gy in 25 fractions to local tumors 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 beginsand 4 1 month after radiotherapy completes DCEMRI will then be done every 3 months until disease progressionSerum samples for angiogenic cytokine studies will also be collectedThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None