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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02284529 |
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Date of registration:
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23/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety of Orectalip® (Oxaliplatin) as Adjuvant Treatment for High-risk Stage-? Colorectal Cancer
Oxaliplatin |
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Scientific title:
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Evaluate the Safety of Combination of Orectalip® (Oxaliplatin), Fluorouracil and Leucovorin as Adjuvant Treatment for High-risk Stage-? Colorectal Cancer |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02284529 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Hwei-Ming Wang, Chief |
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Address:
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Telephone:
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Email:
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Affiliation:
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vghtc.crs@gmail.com |
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Key inclusion & exclusion criteria
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Inclusion Criteria
1. Subject must have World Health Organization performance status score less than 1.
2. Subject must have WBC more than 4,000 cells, platelet count more than 100,000,
absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg,
serum creatinine level less than1.5mg
Exclusion Criteria
1. Subject who has received oxaliplatin treatment
2. Subject who has history of allergy to platinum derivates agents
3. Subject who has decompensated liver function(ALT? AST and alkaline phosphatase more
than 2.5 times of upper limit of normal range).
4. Subject has serious concomitant illness preceding the entry into the study.
5. Female subject who is pregnant or breast feeding.
6. Female subject who is going to be pregnant within 6 months during treatment.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stage-? Colorectal Cancer
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Intervention(s)
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Drug: Orectalip
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Primary Outcome(s)
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To evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study
[Time Frame: 6month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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