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Primary Objective:
To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.
Secondary Objectives:
Full description
Objectives:
Primary Objective:
To compare 3-year disease free survival (DFS) of tegafur-uracil following adjuvant oxaliplatin-based regimen to observation following adjuvant oxaliplatin-based regimen in patients with stage III colon cancer after radical resection.
Secondary Objectives:
Patient Selection and Enrollment:
Number of Subjects: Eligible patients will be randomized in 2 arms in the ratio of 2:1, to reach approximately 546 patients in total.
Plan of the Study:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
To be eligible for inclusion, each subject must fulfill all of the following criteria:
Exclusion criteria
Patients who fulfill any of the following criteria will be excluded from the trial:
previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years;
inadequate hematopoietic function defined as below:
inadequate organ functions defined as below:
other significant medical conditions that are contraindicated to tegafur-uracil or render patient at high risk from treatment complications based on investigator's discretion;
presence of other serious concomitant illness;
participation in another clinical trial with any investigational drug within 30 days prior to entry;
pregnant or lactating women or women of childbearing potential.
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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