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Completed

NCT Number: NCT03665506

Trifluridin/tipirACil in 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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, State of Berlin, 10707, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trifluridin/Tipiracil

Drug

QoL assessment

Other names: QoL assessment

Primary outcomes

  1. Overall survival

    Time frame: Baseline up to 3 years

    time from first administration of trifluridin/tipiracil to death from any cause

Secondary outcomes

  1. Progression-free survival

    Time frame: Baseline up to 3 years

    PFS: time from first administration of trifluridin/tipiracil to disease progression or death from any cause

  2. Overall response rate

    Time frame: Baseline up to 3 years

    ORR: the proportion of patients whose best response was a complete or partial response

  3. Disease control rate 8 weeks

    Time frame: 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

  4. Trifluridin/tipiracil treatment details

    Time frame: 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)

  5. Trifluridin/tipiracil treatment details

    Time frame: Baseline up to 3 years

    Treatment duration

  6. Trifluridin/tipiracil treatment details

    Time frame: Baseline up to 3 years

    Dose intensity (absolute and relative)

  7. Trifluridin/tipiracil treatment details

    Time frame: Baseline up to 3 years

    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.)

  8. AEs and SAEs according to NCI CTCAE

    Time frame: Baseline up to 3 years

    AEs and SAEs according to NCI CTCAE

  9. Safety laboratory values of participants

    Time frame: 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.

  10. Therapy management (use of relevant supportive medications)

    Time frame: Baseline up to 3 years

    Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies)

  11. Patient-reported outcomes (PROs) on quality of life (QoL)

    Time frame: 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.

  12. Patient-reported outcomes (PROs) on quality of life (QoL)

    Time frame: Baseline up to 3 years

    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.

Other outcomes

  1. Time to deterioration of the ECOG performance status

    Time frame: Baseline up to 3 years

  2. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Incidence of hospitalization (Frequencies)

  3. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Frequency of hospitalization (Frequencies)

  4. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Total duration of hospital stays per patient (descriptive statistics)

  5. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Reasons for hospitalizations per patient and per case (Frequencies)

  6. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Number of consultations of various medical specialists

  7. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Incidence of home care (Frequencies)

  8. Assessment of health economic parameters

    Time frame: Baseline up to 3 years

    Location of terminal care (Frequencies)

Sponsors and collaborators

Lead sponsor

Servier

Industry

Collaborators

  • iOMEDICO AG

Registry information

Official study title

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

Acronym: TACTIC

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 11, 2018
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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