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.
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.
Study Type
OBSERVATIONAL
Enrollment
315
QoL assessment
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, State of Berlin, Germany
Overall survival
time from first administration of trifluridin/tipiracil to death from any cause
Time frame: Baseline up to 3 years
Progression-free survival
PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause
Time frame: Baseline up to 3 years
Overall response rate
ORR: the proportion of patients whose best response was a complete or partial response
Time frame: Baseline up to 3 years
Disease control rate 8 weeks
DCR-8: the proportion of patients with a best response of complete or partial response or stable disease, with the assessment of stable disease made at least 8 weeks after first administration of trifluridin/tipiracil
Time frame: Baseline up to 3 years
Trifluridin/tipiracil treatment details
Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen)
Time frame: Baseline
Trifluridin/tipiracil treatment details
Treatment duration
Time frame: Baseline up to 3 years
Trifluridin/tipiracil treatment details
Dose intensity (absolute and relative)
Time frame: Baseline up to 3 years
Trifluridin/tipiracil treatment details
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Treatment sequence (previous and subsequent therapies in relation to Trifluridin/Tipiracil treatment) (Descriptive statistics using frequency tables will be used to assess previous and subsequent palliative systemic antineoplastic treatment regimen used.)
Time frame: Baseline up to 3 years
AEs and SAEs according to NCI CTCAE
AEs and SAEs according to NCI CTCAE
Time frame: Baseline up to 3 years
Safety laboratory values of participants
By-patient display of all safety laboratory results captured as per clinical routine (e.g. CEA, CA 19-9, haemoglobin, neutrophils absolute, lymphocytes count, platelets count, leukocytes count, alkaline phosphatase, ALT (GPT), AST (GOT), bilirubin total and serum creatinine). In addition, CTCAE grades of neutrophils, white blood cell count, platelets, haemoglobin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase and creatinine will be presented using frequencies and percentages for each visit. Shift tables opposing CTCAE grades during treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages.
Time frame: Baseline up to 3 years
Therapy management (use of relevant supportive medications)
Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies)
Time frame: Baseline up to 3 years
Patient-reported outcomes (PROs) on quality of life (QoL)
PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine patients' symptomatic toxicity. Item cluster scores of PRO-CTCAE questionnaire at each visit and change from baseline of scores.
Time frame: Baseline up to 3 years
Patient-reported outcomes (PROs) on quality of life (QoL)
EQ-5D-5L: Questionnaire EQ-5D-5L is used to determine patients' health related quality of life. EQ-5D-5L index and visual analogue score at each visit and change from baseline for both, index and visual analogue score.
Time frame: Baseline up to 3 years