Status:
COMPLETED
A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Pa...
Eligibility Criteria
Inclusion
- histologically confirmed locally advanced rectal cancer;
- measurable disease;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Exclusion
- prior treatment with bevacizumab;
- prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
- previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
- history or evidence of central nervous system (CNS) disease;
- clinically significant cardiovascular disease;
- chronic treatment with high dose aspirin (more than \[\>\] 325 milligrams per day \[mg/day\]) or non-steroidal anti-inflammatory drugs.
Key Trial Info
Start Date :
October 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2016
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00865189
Start Date
October 23 2007
End Date
March 23 2016
Last Update
August 4 2017
Active Locations (40)
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1
ICO Paul Papin; Oncologie Medicale.
Angers, France, 49055
2
Angers, France, 49055
3
HOPITAL JEAN MINJOZ; Oncologie
Besançon, France, 25030
4
Besançon, France, 25030