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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 May 2013 |
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Main ID: |
NCT00700102 |
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Date of registration:
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17/06/2008 |
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Primary sponsor: |
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Public title:
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A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
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Scientific title:
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A Randomized, Open-label Phase III Intergroup Study: Effect of Adding Bevacizumab to Cross Over Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-line Standard CTx/Bevacizumab Combination |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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821 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00700102 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Belgium
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Brazil
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Netherlands
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Norway
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Portugal
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Saudi Arabia
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Spain
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Sweden
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Switzerland
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >=18 years of age
- Metastatic colorectal cancer and disease progression
- Previously treated with first-line chemotherapy plus Avastin
- ECOG <=2.
Exclusion Criteria:
- Diagnosis of progression of disease more than 3 months after last Avastin
administration
- First-line patients with progression-free survival in first-line of <3 months
- Patients receiving less than 3 consecutive months of Avastin in first-line therapy
- Past or current history (within the last 2 years prior to treatment start) of other
malignancies, except for curatively treated basal and squamous cell cancer of the
skin or in situ cancer of the cervix
- Clinically significant cardiovascular disease within 6 months prior to start of study
treatment
- Known CNS disease, except for treated CNS metastases as defined by protocol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Intervention(s)
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Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI
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Drug: bevacizumab [Avastin]
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Drug: FUFOX, FOLFOX, CAPOX or XELOX
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Primary Outcome(s)
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Overall survival (time from randomization to death of any cause)
[Time Frame: approximately 6.5 years]
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Secondary Outcome(s)
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Overall survival from time of starting first-line therapy
[Time Frame: approximately 6.5 years]
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Progression-free survival (after first progression)
[Time Frame: approximately 6.5 years]
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Response rate, tumor assessments according to RECIST criteria
[Time Frame: approximately 6.5 years]
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Safety: Incidence of adverse events
[Time Frame: approximately 6.5 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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