Sirtex Medical

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5345c4b5ee91542f733de87975c8b24c' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study is a randomized multi-center trial that will assess the effect of adding SIRT, using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:5345c4b5ee91542f733de87975c8b24c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Randomised Comparative Study Of Folfox6m Plus Sir-Spheres&#174; Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:2a4b13859bf0e9063bb38d4de3ef4000' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum.</li>\n<li>Measurable evidence of non-resectable liver metastases</li>\n<li>Adequate haematological, renal and hepatic function</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis</li>\n<li>Any extra-hepatic metastases</li>\n<li>Prior chemotherapy for metastatic colorectal cancer</li>\n<li>Pregnant or breast feeding</li>\n</ul>\n</p>', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:573022adc28a5b7d84d49ca2bec433a4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0608031d30eafd757fe57e0af462e45e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as &quot;chemo-SIRT&quot;), for first-line treatment of patients with primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible. This study is designed as a prelude to a planned future randomised comparative study that will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this patient population.</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:0608031d30eafd757fe57e0af462e45e' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Toxicity and safety [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:96222ec9ab994a46f5d3168aeac6844b' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Tumour response rate (liver &#177; any site). [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:008a63982dc80870dd03c3b133d3efdc' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression free survival at any site. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:420420409dfac942df93800359666893' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Progression free survival in the liver. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:2b773dcb17f02702d6a8f653ee2d9b67' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Survival [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:4f622ea780cda3af2b0a11557e94af6a' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Hepatic and extra-hepatic recurrence rate. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:23c724b534f5944f423674c32178d9fc' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Quality of life. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:af012f6b571d3ba8fa5506e6bfd84950' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e0d35b4e863d95d77691c029faf5d016' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Rate of downstaging to surgical resection or ablative therapy. [&nbsp;Time&nbsp;Frame:&nbsp;2 years&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:e0d35b4e863d95d77691c029faf5d016' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:dafcd5a092e9ad09af7adc5386c4b8dd' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:b023ec687951df58ded9e3a6560bab14' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ddb529033d5f336471f60775438190ee' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:ddb529033d5f336471f60775438190ee' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:85a776a0799c5bbbd433ec36b4680171' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Adequate liver function</li>\n<li>Adequate performance status</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Significant extrahepatic disease</li>\n</ul>\n</p>', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:85a776a0799c5bbbd433ec36b4680171' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:66c11ce5274eafb583fd3d0481ba19b9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres&#174; in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient\'s quality of life, and if and how the cancer responds to the treatment.</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:66c11ce5274eafb583fd3d0481ba19b9' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres&#174;) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:a36a299e7a974e475d2b9fb5b552565a' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:190f5c3eb8a6a2d32c50d73c152ab60d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>must have a confirmed diagnosis of HCC.</li>\n<li>at least 18 years of age.</li>\n<li>must have a confirmed diagnosis of HCC either by histological confirmation or, in a subject who exhibits a vascular liver mass in the presence of radiographically apparent cirrhosis, an alpha-fetoprotein (AFP) level greater than 500 UI/ml.</li>\n<li>must present HCC that is not amenable to surgical resection or immediate liver transplantation, or that is not optimally treatable with local ablative techniques such as radio-frequency ablation due to its size, extent or presence of cirrhosis.</li>\n<li>must present measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as greater than or equal to 10 mm with spiral CT scan or greater than or equal to 20 mm using conventional techniques (CT, MRI).</li>\n<li>must present with a whole-liver tumor burden of greater than or equal to 15% and less than or equal to 70%</li>\n<li>must have an ECOG performance status of 2 or less.</li>\n<li>must have normal organ and marrow function</li>\n</ul>\n</p><p> Exclusion criteria: Includes both the listed contraindications to SIR-Spheres&#174; and the exclusion criteria specific to the setting of this investigational study:\n<ul>\n<li>hepatic artery directed therapy within the previous 6 months.</li>\n<li>chemotherapy within the previous 4 weeks</li>\n<li>have not recovered from adverse events due to agents administered previously</li>\n<li>Prior external hepatic radiation therapy for HCC, more than two prior systemic chemotherapy regimes for HCC or any other concomitant therapy for HCC</li>\n<li>Currently receiving any other investigational agents for the treatment of their cancer.</li>\n<li>Any extra-hepatic metastases other than metastatic disease found in the lung, bone and/or abdominal lymph nodes that are not otherwise life limiting.</li>\n<li>Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years.</li>\n<li>Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.</li>\n<li>Any of the following contraindications to angiography and selective visceral catheterization:\n<ul>\n<li>Bleeding diathesis</li>\n<li>Severe peripheral vascular disease</li>\n<li>Portal hypertension with hepatofugal flow</li>\n</ul>\n</li>\n<li>Female subjects who are pregnant or currently breastfeeding.</li>\n<li>Refusal or inability to use effective means of contraception in men or women of childbearing potential.</li>\n<li>Current enrollment in any other investigational drug or device study.</li>\n</ul>\n</p>', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:190f5c3eb8a6a2d32c50d73c152ab60d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to disease progression [&nbsp;Time&nbsp;Frame:&nbsp;from the date of enrollment to the date of documented progression&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:5d9f0d84589f8943b5fb26cc1dc0f1c0' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>tumor response [&nbsp;Time&nbsp;Frame:&nbsp;from the date of enrollment to disease progression or death&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:52505aea1343a0dae8ee7d9c7e66b3a8' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>health related quality of life [&nbsp;Time&nbsp;Frame:&nbsp;12 months&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:4dc2fafebf609b6dac010a61fee74974' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>overall survival [&nbsp;Time&nbsp;Frame:&nbsp;from the date of enrollment to disease progression or death&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283939551, expire = 1284025951, headers = '', serialized = 0 WHERE cid = '1:ee47276772352b9b507decef1666e774' in /persistent/html/includes/cache.inc on line 109.

FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This study is a randomized multi-center trial that will assess the effect of adding SIRT, using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Background information
Trial ID: 
NCT00724503
Other unique IDs: 
STX0206
Official title: 

Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

Detailed description: 

 

Number to be enrolled: 
318 patients
Acronym: 
SIRFLOX

Study of SIR-Spheres Plus Sorafenib as 1st Line Treatment for Non-Resectable Primary HCC

This Phase I/II trial will evaluate the safety and activity of chemo-radiotherapy comprising a regimen of Sorafenib chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), for first-line treatment of patients with primary hepatocellular carcinoma (HCC) in whom surgical resection is not feasible. This study is designed as a prelude to a planned future randomised comparative study that will compare the efficacy of Sorafenib plus SIR-Spheres versus Sorafenib alone, in this patient population.

Background information
Other unique IDs: 
NMRC - AHCC05

Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This trial is testing the safety of combining the oral chemotherapy drug capecitabine with radio-labeled microspheres injected directly into the liver.

Background information
Trial ID: 
NCT00604409
Other unique IDs: 
FCCC04043
Official title: 

Phase I Study of Capecitabine in Combination With SIR-Spheres in Patients With Advanced Cancer

Detailed description: 

Patients with adequate liver function and performance status in whom liver-directed therapy and capecitabine would be appropriate are eligible for this clinical trial.

Number to be enrolled: 
25 patients

SIR-Spheres® for the Treatment of Unresectable Hepatocellular Carcinoma

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The main purpose of this study is to determine the safety and toxicity of treatment with SIR-Spheres® in patients with unresectable primary liver cancer or hepatocellular carcinoma (HCC). Other purposes of this study include assessment of the effect of treatment on overall survival, the length of time it takes for the disease to worsen, if and how the treatment affects the patient's quality of life, and if and how the cancer responds to the treatment.

Background information
Trial ID: 
NCT00503867
Other unique IDs: 
STX 0106
Official title: 

A Pilot Study of Yttrium-90 Microspheres (SIR-Spheres®) Therapy for the Treatment of Unresectable Hepatocellular Carcinoma

Detailed description: 

 

Number to be enrolled: 
40 patients
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