Esophageal Cancer Clinical Trial
Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer
Summary
The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET (Positron Emission Tomography) imaging to predict the degree of pathologic response.
All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).
Eligibility Criteria
Inclusion Criteria:
Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
Histology must be adenocarcinoma or squamous cell carcinoma
Must be surgical candidate based on evaluation by a thoracic surgeon
must have adequate organ function as defined by routine lab tests
Exclusion Criteria:
Insitu carcinoma
prior chemotherapy for esophageal cancer
Metastatic (stage IV disease)
Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within the stomach
Active, uncontrolled cardiac disease
subjects with >Grade 2 neuropathies. -
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There is 1 Location for this study
Madison Wisconsin, 53792, United States
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