Colorectal Cancer Metastatic Clinical Trial
Official title:
A Multicenter, Single Arm, Open Label Clinical Trial Evaluating Safety and Health Related Quality of Life of Aflibercept in Combination With Irinotecan/5FU Chemotherapy (FOLFIRI) in Patients With Metastatic Colorectal Cancer (mCRC) Previously Treated With an Oxaliplatin-Containing Regimen
Primary Objective:
To evaluate the safety of aflibercept in patients with metastatic Colorectal Cancer (mCRC)
treated with irinotecan/5FU combination (FOLFIRI) after failure of an oxaliplatin-based
regimen (patients similar to those evaluated in the VELOUR trial) according to side effects
prevention and management guidelines.
Secondary Objective:
To document the Health-Related Quality of Life (HRQL) of aflibercept in this patient
population.
Each patient will be treated until disease progression, unacceptable toxicity, death, Investigator's decision or patient's refusal for further treatment (whichever come first). Patients will be followed-up during treatment and for at least 30 days after its last study treatment (either aflibercept or FOLFIRI) administration, up to a maximum of 6 months. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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