ZETA : Prospective Observational Study

NCT03730558 | Completed DMC

• 1 other identifier: ZETA 2017-A01724-49
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

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.•

Conditions

Metastatic Colon Cancer

Keywords

metastatic; colon cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

aflibercept + FOLFIRI COMBINATION_PRODUCT

aflibercept + FOLFIRI

Eligibility Criteria

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

Study Population

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) .

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recherche clinique: lead

Study Sites (2)

Institut Sainte-Catherine

Avignon, Vaucluse, 84000, France

Location

Institut Sainte Catherine

Avignon, 84000, France

Location

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm Metastasis

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Laurent Mineur

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: November 5, 2018
• Study Start: November 8, 2017
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: January 22, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)