Trifluridin/tipirACil in MeTastatIc Colorectal Cancer (TACTIC)

Servier

Status: Completed

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: Trifluridin/Tipiracil

Study type: Observational

Funder types: Industry

Identifiers

NCT03665506

IOM-040380

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.