Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
18 Years
N/A
Both
Rectal Cancer
Trial Information
Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathological Complete Response (pCR)
Outcome Time Frame:
11 weeks
Safety Issue:
No
Principal Investigator
Jean-Pascal H Machiels, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
UCL-ONCO 09-001
NCT ID:
NCT00973193
Start Date:
September 2009
Completion Date:
December 2012
Related Keywords:
- Rectal Cancer
- rectum
- colorectal
- cancer
- adenocarcinoma
- anti-EGFR
- monoclonal antibodies
- neoadjuvant therapy
- preoperative radiotherapy
- Rectal Neoplasms
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