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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06678919
Enrollment
500
Registered
2024-11-07
Start date
2024-10-31
Completion date
2034-12-31
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

colorectal

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.

Interventions

None listed

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival10 yearsOverall survival with the respective treatment protocols ≥3L
Progression free survival10 yearsProgression-free survival (PFS) with the respective treatments protocols ≥3L
Overall response rate (ORR)10 yearsOverall response rate (ORR) with the respective ≥3L treatment protocols
Blinded Independent Central Review (BICR)10 yearsBlinded Independent Central Review (BICR) based on the virtual imaging-bank
Identification of predictive biomarkers10 yearsIdentification of predictive biomarkers for mCRC patient sub-cohorts of interest based on the centrally-located bio-bank

Countries

Austria

Contacts

Primary ContactDaniela Wolkersdorfer, Dr.
office@agmt.at+436626404412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026