Transarterial Chemoembolization Versus Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma (TRENDY)
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|ClinicalTrials.gov Identifier: NCT02470533|
Recruitment Status : Recruiting
First Posted : June 12, 2015
Last Update Posted : June 6, 2017
This study will compare head to head in patients with hepatocellular carcinoma (HCC) ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to progression is more favorable after SBRT than after TACE-DEB. The expected time to include the required patients for this trial will be four years.
To the best of the investigators knowledge this study will be the first in the world that will compare both techniques in a randomized trial.
To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.
Randomized, prospective, open-label, and phase II study.
Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤ 6cm, and ≥ 18 years old.
Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT.
Main study parameters/endpoints:
The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression.
Secondary endpoints will be:
- Time to local recurrence
- Response rate (complete and partial response)
- Overall survival
- Quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Liver Neoplasms||Radiation: Radiation therapy Device: chemoembolization||Phase 2|
Primary liver cancer, particularly hepatocellular carcinoma (HCC) is a major health problem. Curative therapies for HCC are considered hepatic resection, liver transplantation and radiofrequency ablation (RFA). Hepatic resection is preferred for patients with limited disease, non-cirrhotic livers or selected patients with Child-Pugh A cirrhosis. Unlike resection, liver transplantation treats the tumor and the underlying cirrhosis present in the liver. Candidates for liver transplantation are preferably those with cirrhosis and tumors that comply with the Milan criteria (single tumor <5cm or 1-3 tumors each of ≤ 3cm). Because most patients are not amenable to resection or liver transplantation, RFA has emerged as an effective treatment option. RFA is limited by the location of the tumor in the liver and by the tumor size with best results after RFA achieved for tumors ≤3cm. For patients that are not eligible for RFA due to large or multifocal tumors, transarterial chemoembolization with drug-eluting beads (TACE-DEB) is the preferred treatment.
Stereotactic body radiation therapy (SBRT) delivers a highly effective dose of irradiation to the tumor while maximally avoiding dose delivery to surrounding healthy structures. SBRT is offered as an ablative local treatment with reported high percentages of complete and partial responses with limited toxicity.
An international expert committee on HCC has recommended time to progression (TTP) as primary endpoint for phase II randomized trials. Although data is scarce the best published median TTP after TACE-DEB was 16 months and after SBRT 36.5months in a more or less comparable patient population (Barcelona Clinic Liver Cancer stage system A-C).
The present study will include patients not eligible for resection or RFA. Patients may be eligible for bridging or for down staging to transplantation. Well compensated liver cirrhosis (Child-Pugh A) and disease confined to the liver (one to three tumors cumulative diameter ≤ 6cm) is required. To our knowledge this trial will be the first in the world to compare TACE-DEB and SBRT. This trial may have a big impact on the control of the disease and may contribute to change the standard of care from a palliative to a more radical/curative intention in this patient population
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transarterial Chemoembolization With Drug-Eluting Beads (Standard Arm) Versus Stereotactic Body Radiation Therapy (Experimental Arm) for Hepatocellular Carcinoma: A Multicenter Randomized Phase II Trial|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Transarterial chemoembolization
Chemoembolization will be performed through a transarterial route delivering drug eluting beads, i.e. hydrogel-based microspheres (Biocompatibles UK, Ltd, HepaSphere Biosphere Medical) loaded with the chemotherapeutic agent doxorubicin.
Up to 4 sessions
Experimental: Stereotactic body radiation therapy
Risk-adapted dose prescription for delivering the highest possible tumor dose not exceeding the maximum dose in 6 fractions of 8-9 Gy, while hepatic normal tissue complication probability (NTCP) < of 5%
Radiation: Radiation therapy
6 fractions of 8-9Gy
- Time to progression [ Time Frame: 4 years ]
- Time to local recurrence [ Time Frame: 4 years ]
- Response rate [ Time Frame: 4 years ]
- Overall survival [ Time Frame: 4 years ]
- Toxicity [ Time Frame: 4 years ]Common toxicity criteria v4.0
- Quality of life [ Time Frame: 4 years ]EORTC Quality of life forms C-30 and HCC-18, Quality of life form Euro QoL5D
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470533
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|Principal Investigator:||Alejandra Mendez Romero, MD PhD||Erasmus Medical Center|
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