Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma
|ClinicalTrials.gov Identifier: NCT02729506|
Recruitment Status : Unknown
Verified March 2016 by Mohamed Ibrahim Alsebayel, King Faisal Specialist Hospital & Research Center.
Recruitment status was: Recruiting
First Posted : April 6, 2016
Last Update Posted : April 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Transarterial Radioembolization Procedure: Transarterial Chemoembolization using drug-eluting beads||Phase 4|
Although 90Y increasingly used in clinical practice, there is no high quality clinical evidence to justify this. Most of the comparison studies are retrospective. Three studies compared TACE with 90Y retrospectively. The first was by Kooby et al in which patients treated with TACE were retrospectively compared to those treated with 90Y suggested that both treatment modalities have similar effectiveness and safety profiles in patients with unresectable HCC. Earlier Carr et al carried out a similar retrospective analysis and concluded that Chemoembolization or Radioembolization appeared to be equivalent regional therapies for patients with unresectable, non-metastatic HCC. More recently Salem et al retrospectively compared 122 HCC patients who received chemo-embolization with 123 patients who received Radioembolization and concluded both patient groups had similar survival times. Radioembolization resulted in longer time-to-progression and less toxicity than chemo-embolization.
A study on down-staging of HCC beyond Milan criteria compare 90Y with TACE of and concluded that 90Y outperforms TACE for down-staging HCC to within transplant criteria.
TACE-DEB is the standardized form TACE with better efficacy and safety profile and will be ideal to use to define the position of 90Y in the of locoregional treatment of HCC.
To date, no prospective studies have been performed comparing both treatment modalities in a randomized setting. This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC.
Known Potential Benefits:
Chemo-embolization is the standard treatment for intermediate HCC with known efficacy and predicted toxicity. The arrival of TAC-DEBs made TACE more efficient, less toxic and more standardized. Y90 Radioembolization is of known efficacy and minimal toxicity base on cohort studies. Head to head comparison has never been conducted.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transarterial Radioembolization Versus Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Arm A
Yttrium-90 Transarterial Radioembolization
Procedure: Transarterial Radioembolization
Yttrium-90 radioembolization (90Y) is a relatively new technique involving the trans-arterial administration of glass or resin microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.
Active Comparator: Arm B
Trans-arterial chemo-embolization using Drug-eluting beads
Procedure: Transarterial Chemoembolization using drug-eluting beads
TACE is a procedure in which a catheter is introduced into the branches of the hepatic artery supplying the tumor. Embolic material and chemotherapeutic agents are deployed through the catheter directly into the tumor vasculature. This technique potentially enhances the cytotoxic effect by inducing ischemia and retention of the therapeutic agent in the vicinity of the tumor.
The drug-eluting beads (DEBs) enable standardization of TACE since DEBs act as both an occluding agent as well as a drug-loaded carrier, achieving local ischemia and cytotoxic death of the tumor with one device.
- Time to Progression (TTP) is the primary outcome. [ Time Frame: 12 month ]
- Time to Local Progression (TLP) [ Time Frame: 12 month ]
- Overall survival [ Time Frame: 12 month ]
- Overall response to therapy according to mRECIST [ Time Frame: 12 month ]
- Toxicities and adverse events [ Time Frame: 12 month ]
- Quality of life [ Time Frame: 12 month ]
- Treatment-related costs, in terms of cost of therapy and number of hospitalization days. [ Time Frame: 12 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729506
|Contact: Mohamed I Al Sebayel, Prof.||+966114647272 ext email@example.com|
|King Faisal Specilist Hopsital & Researchc Center||Recruiting|
|Riyadh, Saudi Arabia, 11211|
|Contact: Mohamed I Al Sebayel, Prof firstname.lastname@example.org|
|Sub-Investigator: Hamad AlSuhaibani, MD, FRCP|
|Sub-Investigator: Faisal Aba AlKhail, MD|
|Sub-Investigator: Ahmad M Al Zahrani, MD|
|Sub-Investigator: Hussien A Elsiesy, MD|
|Principal Investigator:||Mohamed I Al Sebayel, Prof||King Faisal Specilaist Hopsital & Research Center|