Uracil and Tegafur/Leucovorin (UFT/LV) Versus UFT/LV+ Polysaccharide-K (PSK) for Stage IIIa/IIIb Colorectal Cancer

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Iwate Medical University
Updated on 7 November 2020
platelet count
calcium
leucovorin
rectal carcinoma
adenocarcinoma

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 IdentifierNCT00497107
SponsorIwate Medical University
Last Modified on7 November 2020

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