Trifluridin/tipirACil in meTastatIc Colorectal Cancer (TACTIC)

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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 315

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfürstendamm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	time from first administration of trifluridin/tipiracil to death from any cause	Baseline up to 3 years

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Servier Deutschland GmbH
• Collaborators: iOMEDICO AG

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): August 2, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: mCRC; Trifluridin/Tipiracil
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Trifluridine
• Other Study ID Numbers: IOM-040380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No