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Metastatic Colorectal CancerTACTICNCT03665506

Trifluridin/tipirACil in MeTastatIc Colorectal Cancer

An observational study of Metastatic Colorectal Cancer, run by Servier at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Trifluridin/Tipiracil
How many people
315 participants
Where
1 siteGermany
Study dates
25 Jun 2018to 2 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, State of Berlin, 10707

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Trifluridin/Tipiracil
Keywords
mCRC, Trifluridin/Tipiracil
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trifluridin/TipiracilDrug

    Also called QoL assessment

    QoL assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: Baseline up to 3 years

Secondary outcomes (12)

  1. Progression-free survival

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

    Measured: Baseline up to 3 years

  2. Overall response rate

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

    Measured: Baseline up to 3 years

  3. 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

    Measured: Baseline up to 3 years

  4. 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)

    Measured: Baseline

  5. Trifluridin/tipiracil treatment details

    Treatment duration

    Measured: Baseline up to 3 years

  6. Trifluridin/tipiracil treatment details

    Dose intensity (absolute and relative)

    Measured: Baseline up to 3 years

  7. 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.)

    Measured: Baseline up to 3 years

  8. AEs and SAEs according to NCI CTCAE

    AEs and SAEs according to NCI CTCAE

    Measured: Baseline up to 3 years

  9. 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.

    Measured: Baseline up to 3 years

  10. Therapy management (use of relevant supportive medications)

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

    Measured: Baseline up to 3 years

  11. 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.

    Measured: Baseline up to 3 years

  12. 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.

    Measured: Baseline up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2018
  2. Study start25 Jun 2018
  3. Primary completion2 Aug 2021
  4. Study completion2 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03665506
Sponsor's protocol ID
IOM-040380
Acronym
TACTIC
Status last verified
Nov 2021
First submitted
26 Aug 2018
Last updated
3 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37260368

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Colorectal Cancer, run by Servier at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Baseline up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03665506, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.

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