Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer
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- STATUS
- Recruiting
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- participants needed
- 300
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- sponsor
- Iwate Medical University
Summary
The purpose of this study is to conduct a randomised controlled trial (RCT) comparing UFT/LV and UFT/LV + PSK in patients with histological stage IIIa/IIIb colorectal cancer who have undergone curative surgery without residual cancer using 3-year disease free survival (DFS) as the primary endpoint, and also to analyze the 3-year overall survival (OS), compliance, adverse events, quality of life (QOL) and relationship with tumor factors.
Description
To conduct a randomized controlled trial comparing chemotherapy using UFT/LV and immunochemotherapy using UFT/LV combined with PSK in patients with histological stage IIIa and IIIb colorectal cancer (adenocarcinoma) who have undergone curative surgery without residual cancer (R0) using 3-year disease-free survival rate as primary endpoint, and also to analyze the 3-year overall survival, compliance, adverse events, QOL and relationship with tumor factors.
Details
| Condition | Colorectal Cancer |
|---|---|
| Treatment | UFT, Calcium Folinate, PSK, UFT, Calcium Folinate |
| Clinical Study Identifier | NCT00497107 |
| Sponsor | Iwate Medical University |
| Last Modified on | 7 November 2020 |
Eligibility
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