ALTAIR study

ABSTRACT: Interventions: investigational material(s) Generic name etc : Lonsurf combination tablet T15/T20 INN of investigational material : trifluridine + tipiracil hydrochloride Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : In 1 course consisting of 28 days, FTD/TPI or placebo will be orally administered twice daily after breakfast and after dinner for 5 consecutive days (Days 1 to 5 and Days 8 to 12), followed by withdrawal for 2 days. After repeating this cycle twice, the subject is withdrawn from study treatment for 14 days. Primary outcome(s): efficacy Disease-Free Survival 1 (DFS1) The time from the date of enrollment to any of the following events, whichever occurs first: a relapse, the first development of a secondary large intestine carcinoma lesion other than a relapse (an intramucosal cancer lesion will not be treated as an event) that is confirmed after the date of enrollment, and death from any cause. In principle, events will be assessed by the investigator. Study Design: This trial is a randomized, double-blind, multinational Phase III study to evaluate the efficacy and safety of preemptive treatment with FTD/TPI compared with administration of placebo as follow-up, which is the standard of care, in patients who underwent curative resection of colorectal cancer and then tested positive for ctDNA.

DISEASE(S): Colorectal Cancer

PROVIDER: 102757 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR