A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
NCT ID: NCT01227707
Last Updated: 2015-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2005-11-30
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
bevacizumab [Avastin]
5 mg/kg intravenously every 2 weeks, 4 cycles
capecitabine [Xeloda]
825 mg/m2 twice daily orally, 38 days
Radiation therapy
Total dose of 45 Gy over 38 days
Mesorectal excision
6-8 weeks after completion of neoadjuvant treatment
bevacizumab [Avastin]
Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
5-fluorouracil
Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
leucovorin
Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months
Interventions
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bevacizumab [Avastin]
5 mg/kg intravenously every 2 weeks, 4 cycles
capecitabine [Xeloda]
825 mg/m2 twice daily orally, 38 days
Radiation therapy
Total dose of 45 Gy over 38 days
Mesorectal excision
6-8 weeks after completion of neoadjuvant treatment
bevacizumab [Avastin]
Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
5-fluorouracil
Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
leucovorin
Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months
Eligibility Criteria
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Inclusion Criteria
* Patients with confirmed rectal cancer who are subject to surgery and would benefit from pre-operative combined chemo-radiotherapy
* Measurable and/or evaluable lesions according to RECIST criteria
* EOCG performance status 0-1
Exclusion Criteria
* Untreated brain metastases or spinal cord compression or primary brain tumors
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or other medications known to predispose to gastrointestinal ulceration
* Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Ancona, , Italy
Bologna, , Italy
Cuneo, , Italy
Genova, , Italy
Napoli, , Italy
Paola, , Italy
Pisa, , Italy
Roma, , Italy
Siena, , Italy
Countries
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Other Identifiers
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ML18522
Identifier Type: -
Identifier Source: org_study_id
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