Esophageal Cancer Clinical Trial
Official title:
An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with cancer may
help doctors learn more about changes that occur in DNA and identify biomarkers related to
cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying tissue samples in predicting how well chemotherapy
and radiation therapy will kill cancer cells in patients with squamous cell carcinoma of the
esophagus.
OBJECTIVES:
- To search for chemoradiosensitivity-related genes using a pre-treatment biopsy sample
in patients with esophageal squamous cell carcinoma treated with cisplatin,
fluorouracil, and concurrent radiotherapy.
- To establish an algorithm for prediction of chemoradiosensitivity in these patients.
OUTLINE: Patients receive 1 of the following treatment regimens:
- Regimen 1: Patients receive low-dose cisplatin IV on days 1 and 29 and low-dose
fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy on
days 1-4 and 29-32. Patients undergo salvage surgery if needed.
- Regimen 2: Patients receive high-dose cisplatin IV on days 1 and 29 and high-dose
fluorouracil IV on days 1-4 and 29-32. Patients also undergo concurrent radiotherapy
and salvage surgery as in regimen 1.
Pre-operative biopsy samples are analyzed by DNA microarray chip to establish an algorithm
for prediction of chemoradiosensitivity.
After completion of study therapy, patients are followed at 12 months.
;
Masking: Open Label, Primary Purpose: Treatment
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