Preoperative Panitumumab and Radiotherapy in Rectal Cancer
NCT00973193 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2016-04-20
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 adjuvant chemotherapy.
The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.
Conditions
Interventions
- DRUG
-
panitumumab
intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days
Sponsors & Collaborators
-
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
lead OTHER
Principal Investigators
-
Jean-Pascal H Machiels, MD, PhD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2011-09-30
- Completion
- 2012-12-31
Countries
- Belgium
Study Locations
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