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NCT Number: NCT06678919

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 criteria

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

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: 10 years

    Overall survival with the respective treatment protocols ≥3L

  2. Progression free survival

    Time frame: 10 years

    Progression-free survival (PFS) with the respective treatments protocols ≥3L

  3. Overall response rate (ORR)

    Time frame: 10 years

    Overall response rate (ORR) with the respective ≥3L treatment protocols

  4. Blinded Independent Central Review (BICR)

    Time frame: 10 years

    Blinded Independent Central Review (BICR) based on the virtual imaging-bank

  5. Identification of predictive biomarkers

    Time frame: 10 years

    Identification of predictive biomarkers for mCRC patient sub-cohorts of interest based on the centrally-located bio-bank

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Wolkersdorfer, Dr.

CONTACT

[email protected]

+436626404412

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Registry information

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Nov 7, 2024
Registry last updated
Apr 10, 2025

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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