Preoperative Panitumumab and Radiotherapy in Rectal Cancer (PrePaRad)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer|
- Pathological Complete Response (pCR) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]
- Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days
Other Name: Vectibix
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 radiation therapy alone in locally advanced head and neck carcinoma.
Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.
Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.
Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.
|Cliniques Universitaires Saint Luc - Université Catholique de Louvain|
|Brussels, Belgium, 1200|
|Institute Jules Bordet|
|Brussels, Belgium, 1000|
|Centre Hospitalier Notre Dame et Reine Fabiola|
|Charleroi, Belgium, 6000|
|Centre Hospitalier de Jolimont-Lobbes|
|La Louvière, Belgium, 7100|
|Leuven, Belgium, 3000|
|Clinique et Maternité Saint Elizabeth|
|Namur, Belgium, 5000|
|Clinique Saint Pierre|
|Ottignies, Belgium, 1340|
|Clinique Universitaire de Mont Godinne|
|Yvoir, Belgium, 5530|
|Principal Investigator:||Jean-Pascal H Machiels, MD, PhD||Cliniques universitaires Saint-Luc- Université Catholique de Louvain|