At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed colorectal adenocarcinoma
- ✓Underwent radical curative resection of primary and metastatic tumors
- ✓Stage III (T any N1/2 M0) with prior standard postoperative chemotherapy
- ✓ctDNA-positive (SignateraTM) within 3 months of enrollment
- ✕Prior FTD/TPI treatment
- ✕More than one regimen of postoperative adjuvant chemotherapy
- ✕History of prior malignant tumor
- ✕Active infection requiring intervention
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Phase III Study Comparing FTD/TPI Therapy Versus Placebo in Patients Who Are Positive for Blood Circulating Tumor DNA After Curative Resection of Colorectal Cancer
In Brief
A Phase 3 clinical trial evaluating trifluridine and tipiracil and Placebo for Colorectal Neoplasms and 2 related conditions. Completed, enrolled 243 participants across 39 sites in 2 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.