Colorectal Cancer Metastatic Clinical Trial
Official title:
Phase II Study of First-line Capecitabine Plus Oxaliplatin Plus Aflibercept for 6 Cycles Followed by Capecitabine Plus Aflibercept as Maintenance Therapy in Patients With Metastatic Colorectal Cancer: DROP and GO Trial
Primary Objective:
Efficacy: To assess the progression-free survival rate at 10 months in patients on
maintenance therapy with capecitabine plus aflibercept.
Secondary Objectives:
To evaluate:
- Efficacy: Progression Free Survival (PFS)
- Efficacy: Overall Survival (OS)
- Efficacy: Objective Response Rate (ORR) as per Response Evaluation Criteria In Solid
Tumors (RECIST version 1.1) criteria
- Health related Quality of Life (HRQL): EORTC QLQ-C30 scores and EQ5D-3L
- Safety
Exploratory Objective:
To collect blood and tumor samples to perform investigations for potential biomarker
testing.
Total study duration for a participant can be up to 28 months.
This trial is being conducted in countries where the INN designation for the study molecule
is "aflibercept" and this term is therefore used throughout the synopsis. In the US, the US
proper name is "ziv-aflibercept".
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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