Status:
TERMINATED
Preoperative Panitumumab and Radiotherapy in Rectal Cancer
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuv...
Detailed Description
Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over r...
Eligibility Criteria
Inclusion
- ECOG Performance Status 0-1
- Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
- Wild-type KRAS
- No prior pelvic irradiation
- Normal bone marrow, hepatic, renal, cardiac functions
- No secondary malignancy
- No other active, uncontrolled disease
- Signed informed consent
Exclusion
- KRAS mutation
- Established or suspected metastasis
- Prior pelvic irradiation
- Previous exposure to EGFR-targeting therapies
- Patients under any other investigational agent(s)
- Concurrent systemic immune therapy, chemotherapy, hormone therapy
- Drug and/or alcohol abuse
- Grade 3 to 4 allergic reaction to any of the components of the treatment
- History or presence of interstitial lung disease
- Active, uncontrolled cardiovascular disease
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00973193
Start Date
September 1 2009
End Date
December 1 2012
Last Update
April 20 2016
Active Locations (8)
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1
Institute Jules Bordet
Brussels, Belgium, 1000
2
Cliniques Universitaires Saint Luc - Université Catholique de Louvain
Brussels, Belgium, 1200
3
Centre Hospitalier Notre Dame et Reine Fabiola
Charleroi, Belgium, 6000
4
Centre Hospitalier de Jolimont-Lobbes
La Louvière, Belgium, 7100