Preoperative Panitumumab and Radiotherapy in Rectal Cancer (PrePaRad)

This study has been terminated.
(The intermediate analyses did not allowed to continue the clinical study.)
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00973193
First received: September 7, 2009
Last updated: July 12, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Pathological Complete Response (pCR) [ Time Frame: 11 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973193

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
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

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 September 16, 2014