Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM) - NCT00692770-Lima - 00150 (Clinical Trial 224975)
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| City: |
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Lima |
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Country:
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Peru |
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| Conditions: |
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Carcinoma, Hepatocellular |
| Purpose: |
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To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of
Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or
local ablation).
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Subjects who have undergone surgical resection or local ablation (PEI or percutaneous
or intraoperative RFA) for treatment of HCC with curative intent within 4 months from
staging to potentially curative treatment. A maximum of 2 local ablation courses may
be administered during this time period.
- 4 weeks (28 days ± 7 days) from resection or last local ablation course, to CT/MRI
scan date
- Male or female subjects > 18 years of age
- Confirmation of CR (absence of residual tumor after curative treatment), on the
eligibility scan by independent radiological review.
- For subjects undergoing surgical resection pathology proven complete removal of
tumor.
- Intermediate or High Risk of recurrence as assessed by tumor characteristics.
- Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the
absence of ascites.
- ECOG Performance Status of 0.
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Recurrent HCC
- Child-Pugh score 7 points with presence of ascites.
- Low risk of recurrence after curative treatment
- History of cardiovascular disease
- History of HIV infection
- Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
- Subjects with seizure disorder requiring medication (such as steroids or
anti-epileptics)
- Subjects with evidence or history of bleeding diathesis
- Subjects undergoing renal dialysis
- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively
treated > 3 years prior to study entry.
- Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
- Encephalopathy
- History of GI bleeding within 30 days.
- Subjects with a history of esophageal varices bleeding which has not been followed by
effective therapy and/or treatment to prevent bleeding recurrence.
- Prior anti cancer therapy (including sorafenib or any other molecular therapy) is
excluded.
- Major surgery within 4 weeks of start of study, except for surgical resection or local
ablation of HCC.
- Investigational drug therapy outside of this trial during or within 4 weeks of study
entry |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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September 12, 2009 |
Modifications to
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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