AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond

Last updated: April 9, 2025
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06678919
AGMT_mCRC_3L and beyond-Reg
  • Ages > 18
  • All Genders

Study Summary

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States and Europe. Although selected patients with oligometastatic CRC undergo systemic therapy and surgery/local ablative therapy in curative intent, the treatment approach for the majority of metastatic CRC (mCRC) patients remains palliative with a median overall survival (OS) ranging between 9-38 months depending on various prognostic and predictive factors. Particularly in advanced stages (in the third line of therapy and beyond), interesting and promising results have recently been achieved with various treatment approaches. The aim of this registry is to establish a disease-specific registry to evaluate the treatment landscape of patients with mCRC who have already received at least two lines of therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients ≥ 18 years with tissue-based diagnosis of mCRC

  • ≥ 2 prior lines of palliative systemic therapy including 5-FU, irinotecan,oxaliplatin, anti-VEGF, anti-EGFR (in case of RAS/BRAF wildtype), anti-PD1- therapy (in case of MSI/MMRd) . (Exception: Patients who have received mFOLFOXIRI +/-anti-VEGF or anti- EGFR- 1L therapy or patients with ineligibility to receive 5-FU,oxaliplatin or irinotecan can be included after 1st line.)

Exclusion

Exclusion Criteria:

  • Due to the non-interventional design of this registry, there are no specificexclusion criteria

Study Design

Total Participants: 500
Study Start date:
October 31, 2024
Estimated Completion Date:
December 31, 2034

Study Description

This registry aims at retrospectively and prospectively evaluating the treatment landscape and clinical outcome of mCRC ≥3L in a collective attempt by including multiple oncologic centers in Austria.

Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. Imaging studies ≥3L will be centrally collected in a virtual "imaging-bank" and tumor tissue samples of deceased patients will be stored in a central "bio-bank". Additionally, further biomaterial (e.g. ctDNA samples or DNA from DPYD genotyping) may be requested from the centres in case of specific research questions. The patient follow-up data will be obtained until patient death or loss to follow-up.

For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which have already been recorded in the patients' medical charts, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patients' medical and other registry information throughout the lifetime of the registry.

A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.

Data will be collected from all sites willing to participate.

Connect with a study center

  • KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie

    Linz, 4021
    Austria

    Active - Recruiting

  • Ordensklinikum Linz, BHS - Interne I

    Linz, 4010
    Austria

    Active - Recruiting

  • LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)

    Rankweil, 6830
    Austria

    Active - Recruiting

  • Department of Internal Medicine III, Paracelsus Medical University Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie

    Steyr, 4400
    Austria

    Active - Recruiting

  • Klinikum Wels: Abteilung für Innere Medizin IV

    Wels, 4600
    Austria

    Active - Recruiting

  • KH Zams: Innere Medizin Internistische Onkologie und Hämatologie

    Zams, 6511
    Austria

    Active - Recruiting

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