Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) Rate at 12 Months

Outcome Description:

PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

John Zalcberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peter Mc Callum Cancer Centre, Melbourne, Australia

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

EFC10668

NCT ID:

NCT00851084

Start Date:

February 2009

Completion Date:

January 2012

Related Keywords:

• Colorectal Neoplasms
• Neoplasm Metastasis
• Angiogenesis
• Colon cancer
• Rectal cancer
• Oxaliplatin
• Neoplasms
• Colorectal Neoplasms
• Neoplasm Metastasis