ZETA : Prospective Observational Study

Non-comparative Prospective Observational Cohort Study Describing the Safety and Efficacy of Aflibercept Administered in Combination With FOLFIRI After Failure Under Oxaliplatin + Anti-EGFR Therapy in the Treatment of Patients With Metastatic Colorectal Cancer in Practice Common

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03730558

Acronym

ZETA

Enrollment

120

Registered

2018-11-05

Start date

2017-11-08

Completion date

2021-11-08

Last updated

2025-01-22

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

Conditions

Metastatic Colon Cancer

Keywords

metastatic, colon cancer

Brief summary

Primary objective \- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR. Secondary objective * Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate. * Evaluate the tolerance profile of aflibercept in combination with FOLFIRI. * Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•

Detailed description

Inclusion criteria * All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) . * Age ≥18 years * Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin Exclusion criteria : * Concurrent participation in a clinical trial * Patients who have previously received anti-VEGF agents and / or aflibercept in one trial. * Patients who received FOLFIRI in the first metastatic line.

Interventions

COMBINATION_PRODUCTaflibercept + FOLFIRI

aflibercept + FOLFIRI

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) . * Age ≥18 years * Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin

Exclusion criteria

: * Concurrent participation in a clinical trial * Patients who have previously received anti-VEGF agents and / or aflibercept in one trial. * Patients who received FOLFIRI in the first metastatic line

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the efficacy of aflibercept in terms of progression-free survival (PFS) in association with FOLFIRI in patients treated in common practice for metastatic colorectal cancer (CCRM) after failure of oxaliplatin + anti-EGFR-based treatment	2 years	progression-free survival (PFS)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026