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Preoperative Panitumumab and Radiotherapy in Rectal Cancer (PrePaRad)

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ClinicalTrials.gov Identifier: NCT00973193
Recruitment Status : Terminated (The intermediate analyses did not allowed to continue the clinical study.)
First Posted : September 9, 2009
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 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 or disease Intervention/treatment Phase
Rectal Cancer Drug: panitumumab Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
Study Start Date : September 2009
Primary Completion Date : September 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Pathological Complete Response (pCR) [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973193


Locations
Belgium
Institute Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint Luc - Université Catholique de Louvain
Brussels, Belgium, 1200
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
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Principal Investigator: Jean-Pascal H Machiels, MD, PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information

Responsible Party: 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
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

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