Viewing Study NCT00385970



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Study NCT ID: NCT00385970
Status: UNKNOWN
Last Update Posted: 2012-10-26
First Post: 2006-10-08

Brief Title: A Phase III Trial Comparing UFTPSK to UFTLV in Stage IIB III Colorectal Cancer
Sponsor: Multicenter Clinical Study Group of Osaka Colorectal Cancer Treatment Group
Organization: Multicenter Clinical Study Group of Osaka Colorectal Cancer Treatment Group

Study Overview

Official Title: A Phase III Trial Comparing UFTPSK to UFTLV in Stage IIB III Colorectal Cancer
Status: UNKNOWN
Status Verified Date: 2012-10
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To compare the efficacy of tegafururacil UFT plus folinate calcium leucovorin LV administered orally and UFT plus Krestin PSK administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery
Detailed Description: To compare the efficacy of tegafururacil UFT plus folinate calcium leucovorin LV administered orally and UFT plus Krestin PSK administered orally enrolling patients with pTNM stage IIB or III UICC Sixth version colorectal cancerhistological curability A Japanese Classification of Colorectal Carcinoma Sixth version as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None