NCT03665506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2021

Enrollment Period

3.1 years

First QC Date

August 26, 2018

Last Update Submit

November 27, 2024

Conditions

Metastatic Colorectal Cancer

Keywords

mCRCTrifluridin/Tipiracil

Outcome Measures

Primary Outcomes (1)

  • Overall survival

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

    Baseline up to 3 years

Secondary Outcomes (12)

  • Progression-free survival

    Baseline up to 3 years

  • Overall response rate

    Baseline up to 3 years

  • Disease control rate 8 weeks

    Baseline up to 3 years

  • Trifluridin/tipiracil treatment details

    Baseline

  • Trifluridin/tipiracil treatment details

    Baseline up to 3 years

  • +7 more secondary outcomes

Other Outcomes (8)

  • Time to deterioration of the ECOG performance status

    Baseline up to 3 years

  • Assessment of health economic parameters

    Baseline up to 3 years

  • Assessment of health economic parameters

    Baseline up to 3 years

  • +5 more other outcomes

Interventions

Trifluridin/TipiracilDRUG

QoL assessment

Also known as: QoL assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, State of Berlin, 10707, Germany

Location

Related Publications (1)

  • 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.

    PMID: 37260368DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridinetipiracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2018

First Posted

September 11, 2018

Study Start

June 25, 2018

Primary Completion

August 2, 2021

Study Completion

August 2, 2021

Last Updated

December 3, 2024

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)