NCT00660894

Randomized Phase III Study of UFT+Leucovorin vs. TS-1 as Adjuvant Treatment for Stage III Colon Cancer , and Investigate Predictive Factors Based on Gene Expression

Completed Phase 3 Last updated 2 August 2016

What this trial tests

Phase 3 trial testing folinate calcium in Colorectal Cancer in 1,535 participants. Completed in 1 July 2015.

Timeline

1 April 2008

Primary endpoint
1 June 2012

1 July 2015

Quick facts

Lead sponsor	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,535
Start date	1 April 2008
Primary completion	1 June 2012
Estimated completion	1 July 2015
Sites	1 location across Japan

Drugs / interventions tested

• folinate calcium
• tegafur-uracil — full drug profile →
• tegafur-gimeracil-oteracil potassium — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan — full company profile →

Who can join

Adults 20 to 80, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease-free survival

Sponsor's own description

RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, leucovorin, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tegafur-uracil together with leucovorin is more effective than giving S-1 in treating patients with stage III colon cancer.

PURPOSE: This randomized phase III trial is studying giving tegafur-uracil together with leucovorin to see how well it works compared with giving S-1 in treating patients with stage III colon cancer that has been completely removed by surgery.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).
   Yoshida M, Ishiguro M, Ikejiri K, Mochizuki I, et al · · 2014 · cited 79× · PMID 24942277 · DOI 10.1093/annonc/mdu232
2. Safety of UFT/LV and S-1 as adjuvant therapy for stage III colon cancer in phase III trial: ACTS-CC trial.
   Mochizuki I, Takiuchi H, Ikejiri K, Nakamoto Y, et al · · 2012 · cited 34× · PMID 22415232 · DOI 10.1038/bjc.2012.86
3. Updated 5-year survival and exploratory T x N subset analyses of ACTS-CC trial: a randomised controlled trial of S-1 versus tegafur-uracil/leucovorin as adjuvant chemotherapy for stage III colon cancer.
   Kusumoto T, Ishiguro M, Nakatani E, Yoshida M, et al · · 2018 · cited 13× · PMID 30425843 · DOI 10.1136/esmoopen-2018-000428
4. Comparative efficacy and tolerability of adjuvant systemic treatments against resectable colon cancer: a network meta-analysis.
   Cheng J, Shuai X, Gao J, Wang G, et al · · 2020 · cited 3× · PMID 33403014 · DOI 10.1177/1758835920974195