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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorArbeitsgemeinschaft medikamentoese Tumortherapie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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

Trial population

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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Overall Survival

Overall survival with the respective treatment protocols ≥3L

Time frame
10 years
2

Progression free survival

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

Time frame
10 years
3

Overall response rate (ORR)

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

Time frame
10 years
4

Blinded Independent Central Review (BICR)

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

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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