Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT03730558
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.•
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:
NCT03730558
Study Brief:
Protocol Section:
NCT03730558