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

NCT06678919 | Recruiting

• 1 other identifier: AGMT_mCRC_3L and beyond-Reg
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 7

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.

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

colorectal

Outcome Measures

Primary Outcomes (5)

• Overall Survival

  Overall survival with the respective treatment protocols ≥3L

  10 years

• Progression free survival

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

  10 years

• Overall response rate (ORR)

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

  10 years

• Blinded Independent Central Review (BICR)

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

  10 years

• Identification of predictive biomarkers

  Identification of predictive biomarkers for mCRC patient sub-cohorts of interest based on the centrally-located bio-bank

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.)

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (7)

Ordensklinikum Linz, BHS - Interne I

Linz, 4010, Austria

RECRUITING

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

Linz, 4021, Austria

RECRUITING

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

Rankweil, 6830, Austria

RECRUITING

Department of Internal Medicine III, Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

RECRUITING

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

Steyr, 4400, Austria

RECRUITING

Klinikum Wels: Abteilung für Innere Medizin IV

Wels, 4600, Austria

RECRUITING

KH Zams: Innere Medizin Internistische Onkologie und Hämatologie

Zams, 6511, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The Lymphoma registry will be accompanied by an optional biobanking program. Sample collection will be limited to patients that have signed an additional biobanking IC. The samples are taken as part of the clinical routine.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Daniela Wolkersdorfer, Dr.

CONTACT

+436626404412; office@agmt.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

AU (7)