Trial reportTrials2014
Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial.
Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01482442 (A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma), which is not on this map. Cited by 24 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Who cites it
24 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Selective internal radiation therapies for unresectable early-, intermediate- or advanced-stage hepatocellular carcinoma: systematic review, network meta-analysis and economic evaluation.Health technology assessment (Winchester, England) · 2020Pooled it
- Association of adverse events and quality of life in patients with unresectable hepatocellular carcinoma.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Trial
- Trial
- Measure ofEJNMMI reports · 2024Article
- Prophylactic Medication during Radioembolization in Metastatic Liver Disease: Is It Really Necessary? A Retrospective Cohort Study and Systematic Review of the Literature.Diagnostics (Basel, Switzerland) · 2023Article
- Is the Y90-radioembolization treatment effective on the intermediate-advanced stage of hepatocellular carcinoma and what is the albumin-bilirubin score's prediction factor for survival?Hepatology forum · 2023Article
- Article
- Selective Internal Radiation Combined with Chemotherapy Maintains the Quality of Life in Intrahepatic Cholangiocarcinomas.Current oncology (Toronto, Ont.) · 2021Article
- ALBI Score Is a Strong Predictor of Toxicity Following SIRT for Hepatocellular Carcinoma.Cancers · 2021Article
- Impact of contouring methods on pre-treatment and post-treatment dosimetry for the prediction of tumor control and survival in HCC patients treated with selective internal radiation therapy.EJNMMI research · 2021Article
- Liver Resection After Selective Internal Radiation Therapy with Yttrium-90: Safety and Outcomes.Journal of gastrointestinal cancer · 2020Article
- Hepatocellular carcinoma tumor thrombus entering the inferior vena cava treated with percutaneous RF ablation: a case report.Journal of ultrasound · 2019Article
- Treatment Lines in Hepatocellular Carcinoma.Visceral medicine · 2019Review
- Quantitative Imaging Biomarkers forJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2019Article
- Can dual-energy CT replace perfusion CT for the functional evaluation of advanced hepatocellular carcinoma?European radiology · 2018Article
- Fibrolamellar Hepatocellular Carcinoma: Treatment with Yttrium-90 and Subsequent Surgical Resection.Cardiovascular and interventional radiology · 2018Article
- Hepatocellular carcinoma treatment: hurdles, advances and prospects.Hepatic oncology · 2018Review
- Selective internal radiation therapy with SIR-Spheres in hepatocellular carcinoma and cholangiocarcinoma.Journal of gastrointestinal oncology · 2017Review
- New concepts in embolotherapy of HCC.Medical oncology (Northwood, London, England) · 2017Review
- VESPRO: An Individual Patient Data Prospective Meta-Analysis of Selective Internal Radiation Therapy Versus Sorafenib for Advanced, Locally Advanced, or Recurrent Hepatocellular Carcinoma of the SARAH and SIRveNIB Trials.JMIR research protocols · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUntreated advanced hepatocellular carcinoma (HCC) is linked to poor prognosis. While sorafenib is the current recommended treatment for advanced HCC, radioembolisation (RE; also called selective internal radiation therapy or SIRT) with yttrium-90 microspheres has shown efficacy in cohort studies. However, there are no head-to-head trials comparing radiation therapy with yttrium-90 microspheres and sorafenib in advanced HCC. The SARAH trial has been designed to compare the efficacy and safety of sorafenib therapy and RE using yttrium-90 resin microspheres (SIR-Spheres™; Sirtex Medical Limited, North Sydney, Australia) in patients with advanced HCC. Quality of life (QoL) and cost-effectiveness will also be compared between therapies. METHODS/
designSARAH is a prospective, randomised, controlled, open-label, multicentre trial comparing the efficacy of RE with sorafenib in the treatment of patients with advanced HCC. The trial aims to recruit adults with a life expectancy of >3 months, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1, and: advanced HCC according to the Barcelona criteria (stage C) or recurrent HCC after surgical or thermoablative treatment who are not eligible for surgical resection, liver transplantation or thermal ablation; or two rounds of failed chemoembolisation. Patients will be randomised 1:1 to receive either RE or sorafenib 400 mg twice daily. All patients will be monitored for between 12 and 48 months following start of treatment. The primary endpoint of the SARAH trial is overall survival (OS). Secondary endpoints include: adverse events, progression-free survival at 6 months; tumour response rate; general or liver disease-specific QoL scores; and cost of each treatment strategy. Assuming an increase in median OS of 4 months with RE versus sorafenib therapy, randomising at least 400 patients (200 in each treatment arm) will be sufficient for 80% power and a bilateral alpha risk of 5%; therefore, 440 patients will be enrolled to allow for 10% loss of patients due to ineligibility. DISCUSSION: The SARAH trial is the first randomised head-to-head study to compare RE with sorafenib in advanced HCC, and will establish the potential role of RE in HCC treatment guidelines.
trial registrationClinicalTrials.gov identifier NCT01482442, first received 28 November 2011.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.