Status:
COMPLETED
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated. To assess the activity of bevacizumab (AvastinTM) in combination wit...
Detailed Description
See Synopsis
Eligibility Criteria
Inclusion
- Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI - Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3 tumour \< 5 cm from anal verge
- Patient is at least 18 years of age
- Good organ function
Exclusion
- Evidence of distant metastases
- Contraindication for bevacizumab
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00828672
Start Date
June 1 2009
End Date
March 1 2019
Last Update
July 10 2019
Active Locations (9)
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1
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
2
ZNA Middelheim
Antwerp, Belgium, ZNA Middelheim
3
AZ St- Lucas
Bruges, Belgium, 8310
4
Erasme Hospital
Brussels, Belgium, 1070