Trifluridin/tipirACil in meTastatIc Colorectal Cancer

Metastatic Colorectal Cancer Clinical Trial

— TACTIC  

Official title:

A Non-interventional Study to Assess Effectiveness and Safety of Trifluridin/Tipiracil in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665506
• Other study ID #: IOM-040380
• Status: Completed
• Start date: June 25, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: November 2021
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: August 2, 2021
• Est. primary completion date: August 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Trifluridin/Tipiracil
QoL assessment

Locations

Country	Name	City	State
Germany	Onkologische Schwerpunktpraxis Kurfürstendamm	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Servier Deutschland GmbH	iOMEDICO AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to deterioration of the ECOG performance status		Baseline up to 3 years
Other	Assessment of health economic parameters	Incidence of hospitalization (Frequencies)	Baseline up to 3 years
Other	Assessment of health economic parameters	Frequency of hospitalization (Frequencies)	Baseline up to 3 years
Other	Assessment of health economic parameters	Total duration of hospital stays per patient (descriptive statistics)	Baseline up to 3 years
Other	Assessment of health economic parameters	Reasons for hospitalizations per patient and per case (Frequencies)	Baseline up to 3 years
Other	Assessment of health economic parameters	Number of consultations of various medical specialists	Baseline up to 3 years
Other	Assessment of health economic parameters	Incidence of home care (Frequencies)	Baseline up to 3 years
Other	Assessment of health economic parameters	Location of terminal care (Frequencies)	Baseline up to 3 years
Primary	Overall survival	time from first administration of trifluridin/tipiracil to death from any cause	Baseline up to 3 years
Secondary	Progression-free survival	PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause	Baseline up to 3 years
Secondary	Overall response rate	ORR: the proportion of patients whose best response was a complete or partial response	Baseline up to 3 years
Secondary	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
Secondary	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
Secondary	Trifluridin/tipiracil treatment details	Treatment duration	Baseline up to 3 years
Secondary	Trifluridin/tipiracil treatment details	Dose intensity (absolute and relative)	Baseline up to 3 years
Secondary	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
Secondary	AEs and SAEs according to NCI CTCAE	AEs and SAEs according to NCI CTCAE	Baseline up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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