Clinical trial NCT06678919: AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond
Official title: AGMT Metastatic Colorectal Cancer Registry (mCRC) Third Line and Beyond
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: colorectal
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Interested sites that treat patients in this indication will be invited to participate in this registry

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.

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

Primary outcomes:
measure: Overall Survival
timeFrame: 10 years
measure: Progression free survival
timeFrame: 10 years
measure: Overall response rate (ORR)
timeFrame: 10 years
measure: Blinded Independent Central Review (BICR)
timeFrame: 10 years
measure: Identification of predictive biomarkers
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz, BHS - Interne I
city: Linz
country: Austria
facility: KUK Linz - Med Campus III.: Univ.-Klinik für Hämatologie und Internistische Onkologie
city: Rankweil
country: Austria
facility: LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)
city: Salzburg
country: Austria
facility: Department of Internal Medicine III, Paracelsus Medical University Salzburg
city: Steyr
country: Austria
facility: Klinikum Steyr: Innere Medizin II: Onkologie, Gastroenterologie, Angiologie
city: Wels
country: Austria
facility: Klinikum Wels: Abteilung für Innere Medizin IV
city: Zams
country: Austria
facility: KH Zams: Innere Medizin Internistische Onkologie und Hämatologie
Study officials:
References: