Rectal Cancer Clinical Trial
Official title:
Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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