Finding studies
Finding studies
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Lead
Alliance for Clinical Trials in Oncology
With
OBJECTIVES: Primary * To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery. Secondary * To determine the near-complete pathologic response rate in the primary tumor (≤ 10% residual viable cancer). * To determine the overall survival and disease-free survival rates of these patients. * To determine the safety profile of this regimen. OUTLINE: Patients receive panitumumab IV over 1 hour, docetaxel IV over 1 hour, and cisplatin IV over 1-2 hours on day 1 in weeks 1, 3, 5, 7, and 9. Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for 5.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 6-9 weeks after completion of chemoradiotherapy, patients with no evidence of metastatic disease undergo esophagectomy. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year OR every 6 months for 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
