The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,254
oral tablet
intravenous infusion
intravenous oxaliplatin 130 mg/ m\^2(day 1) followed by oral capecitabine 1,000 mg/ m\^2twice daily (day 1 to day 15)
Progression-free Survival
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.
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.
Overall Survival
Number of months from randomisation to the date of death from any cause
Time frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Overall Response Rate
Objective tumour response(defined as a confirmed response of CR or PR).The definition for a confirmed response was met when an initial RECIST response of PR/CR was confirmed at the next scheduled visit as a PR/CR according to an evaluable assessment.Intervening assessments of non-evaluable or stable disease were allowable as long as the initial RECIST response was confirmed.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 lesi
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oral tablet
Research Site
Buenos Aires, Argentina
Research Site
Capital Federal, Argentina
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Research Site
Resistencia, Argentina
Research Site
Rosario, Argentina
Research Site
Santa Fe, Argentina
Research Site
Ashford, Australia
Research Site
Camperdown, Australia
Research Site
Heidelberg, Australia
...and 80 more locations
Time frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Best Percentage Change in Tumour Size
Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions
Time frame: Baseline through to date of death upto and including data cut off date of 21/03/10
Duration of Response
Based on RECIST measurements taken throughout the study and best objective tumour response at the defined analysis cut-off point. Measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies.
Time frame: Treatment period from initial response up until data cut-off date of 21/03/10
Rate of Resection of Liver Metastases
Number of patients undergoing liver resection, based on patients with liver disease at baseline
Time frame: Post-randomisation until end of study
Time to Wound Healing Complications
Number of days from post-randomisation surgery until wound healing complications
Time frame: Post-randomisation until end of study