In:
International Journal of Clinical Trials, Medip Academy, Vol. 4, No. 1 ( 2017-01-25), p. 31-
Abstract:
〈 p class="abstract" 〉 〈 strong 〉 Background: 〈 /strong 〉 Vast majority of patients with hepatocellular carcinoma (HCC) present with unresectable disease. In the last decade results of randomized trials and subsequent meta-analyses established trans-arterial chemoembolization (TACE) as standard of care in patients with Barcelona clinic liver cancer (BCLC) stage B. However, there is clearly a need to investigate additional therapeutic options that would consolidate the initial response to TACE. A recent meta-analyses concluded that addition of radiation to TACE had 10-35% improvement in two-year overall survival, however as results of meta-analyses were based on small studies, the need for conducting a high quality randomized study was highlighted. The present study is designed to investigate the role of high dose stereotactic radiation as consolidation therapy after TACE in patients with non-metastatic unresectable HCC 〈 span lang="EN-IN" 〉 . 〈 /span 〉 〈 /p 〉 〈 p class="abstract" 〉 〈 strong 〉 Methods: 〈 /strong 〉 Patients diagnosed with non-metastatic unresectable HCC with BCLC stage B/A (medically inoperable) and Child-Pugh’s score A-B7 will be eligible. The trial will randomize patients into TACE alone arm or TACE followed by stereotactic body radiation therapy (SBRT). The primary aim is to compare in-field progression free survival (PFS) in phase II and overall survival in phase III between the control (TACE) and intervention arm (TACE+SBRT). The secondary aim is to compare cause specific survival, imaging response and quality of life in control and intervention arms 〈 span lang="EN-IN" 〉 . 〈 /span 〉 〈 /p 〉 〈 p class="abstract" 〉 〈 strong 〉 Results: 〈 /strong 〉 First analysis of the study has been planned when patient accrued under phase II study have completed 1 year follow up 〈 span lang="EN-IN" 〉 . 〈 /span 〉 〈 /p 〉 〈 p class="abstract" 〉 〈 strong 〉 〈 span lang="NL" 〉 〈 br / 〉 〈 /span 〉 〈 /strong 〉 〈 /p 〉 〈 p class="abstract" 〉 〈 strong 〉 〈 span lang="NL" 〉 Trail Registration: 〈 /span 〉 〈 /strong 〉 〈 span lang="NL" 〉 Clinicaltrials.gov,NCT02794337 〈 /span 〉 〈 /p 〉
Type of Medium:
Online Resource
ISSN:
2349-3259
,
2349-3240
DOI:
10.18203/2349-3259.ijct20170306
Language:
Unknown
Publisher:
Medip Academy
Publication Date:
2017