ZETA : Prospective Observational Study (ZETA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03730558|
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : November 7, 2018
- 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.
- 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.•
|Condition or disease||Intervention/treatment|
|Metastatic Colon Cancer||Combination Product: aflibercept + FOLFIRI|
- 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 [Patient Registry]|
|Estimated Enrollment :||120 participants|
|Target Follow-Up Duration:||4 Years|
|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|
|Actual Study Start Date :||November 8, 2017|
|Estimated Primary Completion Date :||November 8, 2021|
|Estimated Study Completion Date :||November 8, 2021|
- Combination Product: aflibercept + FOLFIRI
aflibercept + FOLFIRI
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03730558
|Contact: RANIA BOUSTANY, Dremail@example.com|
|Contact: CELESTE DAVIDfirstname.lastname@example.org|
|Avignon, Vaucluse, France, 84000|
|Contact: Laurent Mineur, Doctor 04 90 27 62 68 email@example.com|
|Principal Investigator: Laurent Mineur, Doctor|
|Institut Sainte Catherine||Recruiting|
|Avignon, France, 84000|
|Contact: RANIA BOUSTANY 0490276161 firstname.lastname@example.org|