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Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer

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ClinicalTrials.gov Identifier: NCT00112918
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : September 6, 2012
Last Update Posted : August 27, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Biological: Bevacizumab
Drug: Capecitabine
Drug: 5-Fluorouracil (5-FU)
Drug: Leucovorin calcium
Drug: Oxaliplatin

  Participant Flow


  Baseline Characteristics


  Outcome Measures

1.  Primary:   Disease-free Survival in Stage III Cancer Patients - Time to Event   [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

2.  Primary:   Disease-free Survival in Stage III Cancer Patients - Number of Events   [ Time Frame: From first patient randomized until the data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

3.  Secondary:   Overall Survival in Stage III Cancer Patients - Time to Event   [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

4.  Secondary:   Overall Survival in Stage III Cancer Patients - Number of Events   [ Time Frame: From first patient randomized until the clinical data cut-off date of 30 June 2010 (36 months after the last patient randomized). ]

5.  Secondary:   Overall Survival in Stage III Cancer Patients - Time to Event: Final Analysis   [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ]

6.  Secondary:   Overall Survival in Stage III Cancer Patients - Number of Events: Final Analysis   [ Time Frame: From first patient randomized until the final data cut-off date of 30 June 2012 (5 years after the last patient randomized). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information