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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02085005
Brief Summary:
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.
Detailed Description:
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".
Study:
NCT02085005
Study Brief:
Protocol Section:
NCT02085005