Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
NCT ID: NCT00828672
Last Updated: 2019-07-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2009-06-30
2019-03-31
Brief Summary
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To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AXE (ARM 1)
Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.
Oxaliplatin
Administered on days 15,22,29,36 en 43; 50 mg/m2
Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
radiotherapy
Total dose 45Gy
AX (ARM 2)
Bevacizumab and Capecitabine concurrently with radiotherapy
Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
radiotherapy
Total dose 45Gy
Interventions
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Oxaliplatin
Administered on days 15,22,29,36 en 43; 50 mg/m2
Bevacizumab
Administered on days 1,15,29 and 43 ; 5mg/kg
Capecitabine
825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy
radiotherapy
Total dose 45Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is at least 18 years of age
* Good organ function
Exclusion Criteria
* Contraindication for bevacizumab
* Pregnant or breastfeeding women.
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Eric Van Cutsem, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven
Locations
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Onze Lieve Vrouwziekenhuis
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
AZ St- Lucas
Bruges, , Belgium
Erasme Hospital
Brussels, , Belgium
Cliniques Universitaires St Luc
Brussels, , Belgium
AZ Groeninge
Kortrijk, , Belgium
C.H.U. Sart-Tilman
Liège, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
H. Hartziekenhuis
Roeselare, , Belgium
Countries
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Other Identifiers
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2007-007177-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO19051
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
s51104 - ML5194
Identifier Type: -
Identifier Source: org_study_id
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