SorAfenib Versus RADIOEMBOLIZATION in Advanced Hepatocellular Carcinoma (SARAH)
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ClinicalTrials.gov Identifier: NCT01482442 |
Recruitment Status :
Completed
First Posted : November 30, 2011
Last Update Posted : January 16, 2017
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Condition or disease | Intervention/treatment | Phase |
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Liver Carcinoma | Drug: sorafenib Drug: SIR-Sphere | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 496 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized Open-labeled Trial Comparing RADIOEMBOLIZATION With Yttrium 90 Microspheres and Sorafenib in Patients With Advanced Hepatocellular Carcinoma |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | April 2016 |
Actual Study Completion Date : | April 2016 |
Arm | Intervention/treatment |
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Active Comparator: sorafenib group
Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. At the discretion of the investigator, the dose may be re-escalated to after the resolution of the adverse event.
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Drug: sorafenib
Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. At the discretion of the investigator, the dose may be re-escalated to after the resolution of the adverse event. |
Active Comparator: radioembolization group
The first step will check patient eligibility and prepare conditioning by performing selective mesenteric and hepatic angiography (to document the arterial tumor supply and to occlude extrahepatic vessels) and 99mTc-macroaggregated albumin scintigraphy. The second step is RADIOEMBOLIZATION therapy. One to two weeks after patient eligibility and conditioning, treatment is performed with SIR-Sphere (SIRTEX Medical Ltd.,Lane Cove,Australia).
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Drug: SIR-Sphere
The first step will check patient eligibility and prepare conditioning by performing selective mesenteric and hepatic angiography (to document the arterial tumor supply and to occlude extrahepatic vessels) and 99mTc-macroaggregated albumin scintigraphy. The second step is RADIOEMBOLIZATION therapy. One to two weeks after patient eligibility and conditioning, treatment is performed with SIR-Sphere (SIRTEX Medical Ltd.,Lane Cove,Australia). |
- Median overall survival time [ Time Frame: 36 months ]Median overall survival time since randomisation
- Common Terminology Criteria for Adverse Events [ Time Frame: 36 months ]Adverse events reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
- Progression-free survival [ Time Frame: month 6 ]Progression-free survival at 6 months
- Response rate [ Time Frame: 36 months ]Response rate (complete response, partial response, stable disease)
- General and hepatic specific quality of life scores [ Time Frame: 36 months ]General and hepatic specific quality of life scores
- Health care costs [ Time Frame: 36 months ]Health care costs which comprise 2 parts: 1) the microcosting of Y90 radioembolization from the viewpoint of the hospital and 2) the full cost of each strategy
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to RECIST criteria by CT-scan or MRI
- Adult over 18 years old and estimated life expectancy over 3 months
- Patient with advanced HCC according to BCLC staging system (stage C) with or without portal vein thrombosis, not eligible for surgical resection, liver transplantation nor radiofrequency ablation OR patient with progression or recurrence of HCC after surgical or locoregional treatment not eligible for surgical resection, liver transplantation nor radiofrequency ablation OR patients in whom chemoembolisation has failed after two courses (patients who have received only one course of chemoembolisation are eligible if the failure of the first round shows that a second round will have no more impact; patients who have received more than two courses of chemoembolisation are still eligible if the arterial network is perfectly normal on a CT scan in the arterial phase). Failure is defined as the absence of an objective response after two courses of treatment in the treated nodule (objective response according to modified RECIST criteria and/or EASL criteria).
- ECOG performance status under or equals 1
- Adequate haematological function: Hb over or equals 9g/100mL, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
- Adequate renal function; serum creatinine under 150μmol/L
- Bilirubin under or equals 50 µmol/L, AST or ALT uner or equals 5 x ULN, INR under or equals 1.5
- Liver cirrhosis Child Pugh A - B7
- written informed consent
Exclusion Criteria:
- Another primary tumour, with the exception of conventional basal cell carcinoma or superficial bladder neoplasia
- Extrahepatic metastasis
- Advanced HCC previously treated
- Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy Women who are pregnant or breast feeding
- Allergy to contrast media
- Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation
- Psychiatric or other disorder likely to impact on informed consent
- Patient unable and/or unwilling to comply with treatment and study instructions
- Patient unable to swallow oral medications
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): NCT01482442
Principal Investigator: | Valerie Vilgrain, PD, PhD | Department of radiology |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT01482442 |
Other Study ID Numbers: |
P101103 |
First Posted: | November 30, 2011 Key Record Dates |
Last Update Posted: | January 16, 2017 |
Last Verified: | January 2017 |
Liver, HCC Liver, interventional procedures Liver, randomized studies Liver, targeted therapy Liver, RADIOEMBOLIZATION |
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Sorafenib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |