Clinical trial · Observational
Trifluridin/tipirACil in MeTastatIc Colorectal Cancer
A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/tipiracil in Patients with Metastatic Colorectal Cancer
NCT03665506CI-TRIAL-00083244TACTICcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A non-interventional, prospective, open, multicenter study in Germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trifluridin/Tipiracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Baseline up to 3 years
- description
- time from first administration of trifluridin/tipiracil to death from any cause
Secondary outcomes (12)
- measure
- Progression-free survival
- timeFrame
- Baseline up to 3 years
- description
- PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause
- measure
- Overall response rate
- timeFrame
- Baseline up to 3 years
- description
- ORR: the proportion of patients whose best response was a complete or partial response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 years or older. * Patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents. * Indication for treatment as assessed by the treating physician. * Decision for treatment with trifluridin/tipiracil. * Signed written informed consent. * Criteria according to current Summary of Product Characteristics (SmPC) for patients treated with trifluridin/tipiracil. * Ability to read and understand German. Exclusion Criteria: * Contraindications according to SmPC for metastatic colorectal cancer patients treated with trifluridin/tipiracil. * Participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.
References
Publications (1)
- DERIVEDKroning H, Gohler T, Decker T, Grundeis M, Kojouharoff G, Lipke J, Semsek D, Moorahrend E, Sauer A, Bruch HR, Liersch R, Nusch A, Vehling-Kaiser U, Welslau M, Grunewald R, Harich HD, Stephany M, Uhlig J, de Buhr R, Frank M, Hogrefe C, Marschner N, Potthoff K, Hartmann F, Reislander T, Schwaner I. Effectiveness, safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real-world data from the noninterventional TACTIC study in Germany. Int J Cancer. 2023 Sep 15;153(6):1227-1240. doi: 10.1002/ijc.34603. Epub 2023 Jun 1. PMID 37260368