Metastatic Colorectal Cancer
Conditions
Keywords
mCRC, 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.
Interventions
DRUGTrifluridin/Tipiracil
QoL assessment
Sponsors
iOMEDICO AG
Servier
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Baseline up to 3 years | time from first administration of trifluridin/tipiracil to death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Baseline up to 3 years | PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause |
| Overall response rate | Baseline up to 3 years | ORR: the proportion of patients whose best response was a complete or partial response |
| Disease control rate 8 weeks | Baseline up to 3 years | 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 |
| Trifluridin/tipiracil treatment details | Baseline | Line of Trifluridin/Tipiracil treatment (Descriptive statistics using frequency tables will be used to assess the number of prior palliative systemic antineoplastic treatment regimen) |
| Therapy management (use of relevant supportive medications) | Baseline up to 3 years | Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) |
| Patient-reported outcomes (PROs) on quality of life (QoL) | Baseline up to 3 years | 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. |
| AEs and SAEs according to NCI CTCAE | Baseline up to 3 years | AEs and SAEs according to NCI CTCAE |
| Safety laboratory values of participants | Baseline up to 3 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to deterioration of the ECOG performance status | Baseline up to 3 years | — |
| Assessment of health economic parameters | Baseline up to 3 years | Incidence of hospitalization (Frequencies) |
Countries
Germany
Outcome results
None listed