- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730558
ZETA : Prospective Observational Study (ZETA)
November 5, 2018 updated by: Dr.Laurent Mineur
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
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.•
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: RANIA BOUSTANY, Dr
- Phone Number: 0490276161
- Email: r.boustany@isc84.org
Study Contact Backup
- Name: CELESTE DAVID
- Phone Number: 0490276161
- Email: c.david@isc84.org
Study Locations
-
-
-
Avignon, France, 84000
- Recruiting
- Institut Sainte Catherine
-
Contact:
- RANIA BOUSTANY
- Phone Number: 0490276161
- Email: r.boustany@isc84.org
-
-
Vaucluse
-
Avignon, Vaucluse, France, 84000
- Recruiting
- Institut Sainte-Catherine
-
Contact:
- Laurent Mineur, Doctor
- Phone Number: 04 90 27 62 68
- Email: l.mineur@isc84.org
-
Principal Investigator:
- Laurent Mineur, Doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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) .
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 2 years
|
progression-free survival (PFS)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2017
Primary Completion (Anticipated)
November 8, 2021
Study Completion (Anticipated)
November 8, 2021
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
November 2, 2018
First Posted (Actual)
November 5, 2018
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Colorectal Neoplasms
- Colonic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Aflibercept
Other Study ID Numbers
- ZETA 2017-A01724-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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