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

NCT ID: NCT06678919

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2034-12-31

Brief 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.

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)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ordensklinikum Linz, BHS - Interne I

Linz, , Austria

Site Status: RECRUITING

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

Linz, , Austria

Site Status: RECRUITING

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

Rankweil, , Austria

Site Status: RECRUITING

Department of Internal Medicine III, Paracelsus Medical University Salzburg

Salzburg, , Austria

Site Status: RECRUITING

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

Steyr, , Austria

Site Status: RECRUITING

Klinikum Wels: Abteilung für Innere Medizin IV

Wels, , Austria

Site Status: RECRUITING

KH Zams: Innere Medizin Internistische Onkologie und Hämatologie

Zams, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Daniela Wolkersdorfer, Dr.

Role: CONTACT

office@agmt.at

+436626404412

Facility Contacts

Florian Huemer, Priv.Doz. Dr

Role: primary

f.huemer@salk.at

+435725557082

Other Identifiers

AGMT_mCRC_3L and beyond-Reg

Identifier Type: -

Identifier Source: org_study_id