ZETA : Prospective Observational Study

Metastatic Colon Cancer Clinical Trial

— ZETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730558
• Other study ID #: ZETA 2017-A01724-49
• Status: Recruiting
• Start date: November 8, 2017
• Est. completion date: November 8, 2021

Study information

• Verified date: November 2018
• Source: Institut Sainte Catherine
• Contact: RANIA BOUSTANY, Dr
• Phone: 0490276161
• Email: r.boustany[@]isc84.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.•

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Metastatic Colon Cancer

Intervention

Combination Product:
• aflibercept + FOLFIRI
aflibercept + FOLFIRI

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Institut Sainte-Catherine	Avignon	Vaucluse

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Laurent Mineur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression-free survival (PFS)	2 years