Status:
COMPLETED
A Study of Avastin (Bevacizumab) Plus Xeloda (Capecitabine) in Patients With Locally Advanced Rectal Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuva...
Eligibility Criteria
Inclusion
- Adult patients, \>=18 years of age
- 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
- Prior radiotherapy or chemotherapy for rectal cancer
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01227707
Start Date
November 1 2005
End Date
August 1 2010
Last Update
August 17 2015
Active Locations (9)
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1
Ancona, Italy, 60121
2
Bologna, Italy, 40139
3
Cuneo, Italy, 12100
4
Genova, Italy, 16132