Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival

Outcome Description:

RECIST criteria defined as follows: Target lesions Complete Response (CR) Disappearance of all target lesions Partial Response (PR) At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum LD.Progressive Disease (PD) At least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded (either at baseline or at previous assessment since treatment began).Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non-target lesions Complete Response (CR) Disappearance of all non-target lesions Non-Complete Response (non-CR/Non- Progression [non-PD]) Persistence of one or more non-target lesion or/and maintenance of tumour marker level above the normal limits. Progression (PD) Unequivocal progression of existing nontarget lesions.

Outcome Time Frame:

RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest.

Safety Issue:

No

Principal Investigator

Jane Robertson

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

D8480C00051

NCT ID:

NCT00399035

Start Date:

November 2006

Completion Date:

May 2013

Related Keywords:

• Metastatic Colorectal Cancer
• Colorectal Cancer
• Cediranib
• RECENTIN
• Colorectal Neoplasms