Trifluridin/tipirACil in MeTastatIc Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

315 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-25

Study Completion Date

2021-08-02

Brief Summary

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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.

Detailed Description

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The purpose of this NIS, after market approval of trifluridin/tipiracil as treatment for mCRC patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, QoL, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. In addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.

Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Trifluridin/Tipiracil

QoL assessment

Intervention Type DRUG

Other Intervention Names

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QoL assessment

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Kroning 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.

Reference Type DERIVED

PMID: 37260368 (View on PubMed)

Other Identifiers

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IOM-040380

Identifier Type: -

Identifier Source: org_study_id