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Metastatic Colorectal Cancer (mCRC)NCT06678919

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

An observational study of Metastatic Colorectal Cancer (mCRC), run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer (mCRC)
How many people
500 participants
Where
7 sitesAustria
Study dates
31 Oct 2024to Dec 2034
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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: Interested sites that treat patients in this indication will be invited to participate in this registry

Who may be able to join

  • 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.)

Who cannot join

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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniela Wolkersdorfer, Dr. contact

+436626404412

office@agmt.at

7 sites in 1 country

Austria7 sites, 7 recruiting

  • Ordensklinikum Linz, BHS - Interne I

    Linz, 4010

    Holger Rumpold, MD

    Recruiting

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

    Linz, 4021

    Clemens Schmitt, MD

    Recruiting

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

    Rankweil, 6830

    Thomas Winder, MD

    Recruiting

  • Department of Internal Medicine III, Paracelsus Medical University Salzburg

    Salzburg, 5020

    Florian Huemer, Priv.Doz. Dr, +435725557082, f.huemer@salk.at

    Florian Huemer, Priv. Doz. Dr.

    Recruiting

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

    Steyr, 4400

    Georg Schreil, MD

    Recruiting

  • Klinikum Wels: Abteilung für Innere Medizin IV

    Wels, 4600

    Sonja Heibl, MD

    Recruiting

  • KH Zams: Innere Medizin Internistische Onkologie und Hämatologie

    Zams, 6511

    Ewald Wöll, MD

    Recruiting

Other trials in Austria

About this study

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.

Read the detailed 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.

Keywords
colorectal
Medical subject headings
Colorectal Neoplasms

What is being measured

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

  1. Overall Survival

    Overall survival with the respective treatment protocols ≥3L

    Measured: 10 years

  2. Progression free survival

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

    Measured: 10 years

  3. Overall response rate (ORR)

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

    Measured: 10 years

  4. Blinded Independent Central Review (BICR)

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

    Measured: 10 years

  5. Identification of predictive biomarkers

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

    Measured: 10 years

Timeline

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

  1. First posted7 Nov 2024
  2. Study start31 Oct 2024
  3. Primary completionDec 2034 (estimated)
  4. Study completionDec 2034 (estimated)

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
Other
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678919
Sponsor's protocol ID
AGMT_mCRC_3L and beyond-Reg
Status last verified
Apr 2025
First submitted
6 Nov 2024
Last updated
10 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huemer F, Piringer G, Eisterer W, Heibl S, Rumpold H, Woll E, Schreil G, Sliwa T, Winder T, Prager G, Grunberger B, Moik F, Amann A, Taghizadeh H, Niedersuss-Beke D, Greil R, Weiss L. AGMT mCRC Registry Third-Line and Beyond: a multicentric real-world platform with integrated imaging and biosample database for later-line metastatic colorectal cancer. Future Oncol. 2026 Apr;22(9):1047-1053. doi: 10.1080/14796694.2026.2644463. Epub 2026 Mar 20.

    PubMed 41860053

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Colorectal Cancer (mCRC), run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 7 sites in Austria.

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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Austria. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Daniela Wolkersdorfer, Dr. (+436626404412, office@agmt.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 10 years). The study lists 5 primary outcomes in all. 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 NCT06678919, 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 10 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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