ZETA : Prospective Observational Study

Recherche clinique

Status: Completed

Conditions: Metastatic Colon Cancer

Treatments: Combination Product: aflibercept + FOLFIRI

Study type: Observational

Funder types: Other

Identifiers

NCT03730558

ZETA 2017-A01724-49

Details and patient eligibility

About

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.•

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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