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Clinical Trials/NCT06678919
NCT06678919
Recruiting
Not Applicable

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

Arbeitsgemeinschaft medikamentoese Tumortherapie7 sites in 1 country500 target enrollmentOctober 31, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Colorectal Cancer (mCRC)
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Enrollment
500
Locations
7
Primary Endpoint
Overall Survival
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2024
End Date
December 2034
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Responsible Party
Sponsor

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.)

Exclusion Criteria

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

Outcomes

Primary Outcomes

Overall Survival

Time Frame: 10 years

Overall survival with the respective treatment protocols ≥3L

Progression free survival

Time Frame: 10 years

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

Overall response rate (ORR)

Time Frame: 10 years

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

Blinded Independent Central Review (BICR)

Time Frame: 10 years

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

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

Study Sites (7)

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