Preoperative Panitumumab and Radiotherapy in Rectal Cancer (PrePaRad)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Cancer |
Drug: panitumumab |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 20 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: panitumumab |
Drug: panitumumab
intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days
Other Name: Vectibix
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations| Belgium | |
| 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 | |
| UZ Gasthuisberg | |
| 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 |
More Information
No publications provided
| Responsible Party: | Jean-Pascal Machiels, MD, PhD, Cliniques Universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT00973193 History of Changes |
| Other Study ID Numbers: | UCL-ONCO 09-001, Academic study |
| Study First Received: | September 7, 2009 |
| Last Updated: | July 12, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
|
rectum colorectal cancer adenocarcinoma |
anti-EGFR monoclonal antibodies neoadjuvant therapy preoperative radiotherapy |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013