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.
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
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.
7 sites in 1 country
Austria7 sites, 7 recruiting
- 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
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.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Keywords
- colorectal
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival with the respective treatment protocols ≥3L
Measured: 10 years
Progression free survival
Progression-free survival (PFS) with the respective treatments protocols ≥3L
Measured: 10 years
Overall response rate (ORR)
Overall response rate (ORR) with the respective ≥3L treatment protocols
Measured: 10 years
Blinded Independent Central Review (BICR)
Blinded Independent Central Review (BICR) based on the virtual imaging-bank
Measured: 10 years
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.
- First posted7 Nov 2024
- Study start31 Oct 2024
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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