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| Name | Class |
|---|---|
| iOMEDICO AG | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trifluridin/Tipiracil | Drug | QoL assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | time from first administration of trifluridin/tipiracil to death from any cause | Baseline up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause | Baseline up to 3 years |
| Overall response rate | ORR: the proportion of patients whose best response was a complete or partial response |
| Measure | Description | Time Frame |
|---|---|---|
| Time to deterioration of the ECOG performance status | Baseline up to 3 years | |
| Assessment of health economic parameters | Incidence of hospitalization (Frequencies) | Baseline up to 3 years |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | State of Berlin | 10707 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37260368 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014271 | Trifluridine |
| C000613754 | tipiracil |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 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 | 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) | Baseline |
| Trifluridin/tipiracil treatment details | Treatment duration | Baseline up to 3 years |
| Trifluridin/tipiracil treatment details | Dose intensity (absolute and relative) | Baseline up to 3 years |
| Trifluridin/tipiracil treatment details | 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.) | Baseline up to 3 years |
| AEs and SAEs according to NCI CTCAE | AEs and SAEs according to NCI CTCAE | 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. | 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) | 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. | 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. | Baseline up to 3 years |
| Assessment of health economic parameters | Frequency of hospitalization (Frequencies) | Baseline up to 3 years |
| Assessment of health economic parameters | Total duration of hospital stays per patient (descriptive statistics) | Baseline up to 3 years |
| Assessment of health economic parameters | Reasons for hospitalizations per patient and per case (Frequencies) | Baseline up to 3 years |
| Assessment of health economic parameters | Number of consultations of various medical specialists | Baseline up to 3 years |
| Assessment of health economic parameters | Incidence of home care (Frequencies) | Baseline up to 3 years |
| Assessment of health economic parameters | Location of terminal care (Frequencies) | Baseline up to 3 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |