Clinical trial NCT03665506: Trifluridin/tipirACil in MeTastatIc Colorectal Cancer
Official title: A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/tipiracil in Patients with Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
Trifluridin/Tipiracil
Lead sponsor: Servier
Sponsor class: INDUSTRY
Collaborators: name: iOMEDICO AG
First posted: 2018-09-11
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF (vascular endothelial growth factor) agents, and anti-EGFR (epidermal growth factor receptor) agents and with decision for treatment with trifluridin/tipiracil.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: Baseline up to 3 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Baseline up to 3 years
measure: Overall response rate
timeFrame: Baseline up to 3 years
measure: Disease control rate 8 weeks
timeFrame: Baseline up to 3 years
measure: Trifluridin/tipiracil treatment details
timeFrame: Baseline
measure: Trifluridin/tipiracil treatment details
timeFrame: Baseline up to 3 years
measure: Trifluridin/tipiracil treatment details
timeFrame: Baseline up to 3 years
measure: Trifluridin/tipiracil treatment details
timeFrame: Baseline up to 3 years
measure: AEs and SAEs according to NCI CTCAE
timeFrame: Baseline up to 3 years
measure: Safety laboratory values of participants
timeFrame: Baseline up to 3 years
measure: Therapy management (use of relevant supportive medications)
timeFrame: Baseline up to 3 years
measure: Patient-reported outcomes (PROs) on quality of life (QoL)
timeFrame: Baseline up to 3 years
measure: Patient-reported outcomes (PROs) on quality of life (QoL)
timeFrame: Baseline up to 3 years
Other outcomes:
measure: Time to deterioration of the ECOG performance status
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
measure: Assessment of health economic parameters
timeFrame: Baseline up to 3 years
Locations:
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
Study officials:
References: