An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
- 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
1-year progression-free survival
Yutaka Shimada, MD, PhD
Toyama University Hospital