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

April 9, 2025 updated by: Arbeitsgemeinschaft medikamentoese Tumortherapie

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.

Study Overview

Status

Recruiting

Conditions

Metastatic Colorectal Cancer (mCRC)

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Daniela Wolkersdorfer, Dr.
Phone Number: +436626404412
Email: office@agmt.at

Study Locations

Austria
- - Linz, Austria, 4010
    - Recruiting
    - Ordensklinikum Linz, BHS - Interne I
    - Contact:
      
      Holger Rumpold, MD
  - Linz, Austria, 4021
    - Recruiting
    - KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie
    - Contact:
      
      Clemens Schmitt, MD
  - Rankweil, Austria, 6830
    - Recruiting
    - LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)
    - Contact:
      
      Thomas Winder, MD
  - Salzburg, Austria, 5020
    - Recruiting
    - Department of Internal Medicine III, Paracelsus Medical University Salzburg
    - Contact:
      
      Florian Huemer, Priv.Doz. Dr
      
      Phone Number: +435725557082
      
      Email: f.huemer@salk.at
    - Contact:
      
      Florian Huemer, Priv. Doz. Dr.
    - Contact:
      
      Lukas Weiss, Priv. Doz. Dr. med. univ.
    - Contact:
      
      Konstantin Schlick, Priv.-Doz. Dr.
  - Steyr, Austria, 4400
    - Recruiting
    - Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie
    - Contact:
      
      Georg Schreil, MD
  - Wels, Austria, 4600
    - Recruiting
    - Klinikum Wels: Abteilung für Innere Medizin IV
    - Contact:
      
      Sonja HEIBL, MD
  - Zams, Austria, 6511
    - Recruiting
    - KH Zams: Innere Medizin Internistische Onkologie und Hämatologie
    - Contact:
      
      Ewald Wöll, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: 10 years	Overall survival with the respective treatment protocols ≥3L	10 years
Progression free survival Time Frame: 10 years	Progression-free survival (PFS) with the respective treatments protocols ≥3L	10 years
Overall response rate (ORR) Time Frame: 10 years	Overall response rate (ORR) with the respective ≥3L treatment protocols	10 years
Blinded Independent Central Review (BICR) Time Frame: 10 years	Blinded Independent Central Review (BICR) based on the virtual imaging-bank	10 years
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	10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

colorectal

Additional Relevant MeSH Terms

Other Study ID Numbers

AGMT_mCRC_3L and beyond-Reg

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.