Study of Tissue Samples in Predicting How Well Chemotherapy and Radiation Therapy Will Kill Cancer Cells in Patients With Squamous Cell Carcinoma of the Esophagus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: fluorouracil
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the thoracic esophagus Stage IIA, IIB, or III (except T4) disease Tumor diameter < 8 cm No tumor extension to the cervical esophagus or cardia of the stomach No multiple and different histological types of cancer PATIENT CHARACTERISTICS: ECOG performance status 0-1 WBC ≥ 4,000/mm³ Absolute neutrophil count ≥ 2,000/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL AST and ALT ≤ 100 IU/L Total serum bilirubin ≤ 1.5 mg/dL Creatinine ≤ 1.2 mg/dL Creatinine clearance ≥ 60mL/min SpO_2 (room air) ≥ 95% Not pregnant or nursing No abnormal ECG findings requiring treatment No interstitial pneumonitis or no pulmonary fibrosis No severe complication (e.g., heart failure, renal failure, hepatic failure, or uncontrollable diabetes mellitus) No collagen disease (e.g., PSS or dermatomyositis) No mental disease No active bacterial infection No virus infection (i.e., HBV, HCV, PTHA, or HIV) PRIOR CONCURRENT THERAPY: No prior surgery for esophageal cancer No prior chemotherapy No prior chest radiotherapy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen 1<br>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. | Drug: cisplatin<br>* Given IV<br>Drug: fluorouracil<br>* Given IV<br>Radiation: radiation therapy<br>* Patients undergo radiotherapy<br>|
| Experimental: Regimen 2<br>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. | Drug: cisplatin<br>* Given IV<br>Drug: fluorouracil<br>* Given IV<br>Radiation: radiation therapy<br>* Patients undergo radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year progression-free survival |  |  | 
| 1-year local progression-free survival |  |  | 
| 3-year progression-free survival |  |  | 
| 3-year overall survival |  |  | 
| Complete histological response |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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squamous cell carcinoma of the esophagus, stage IIA esophageal cancer, stage IIB esophageal cancer, stage IIIA esophageal cancer, stage IIIB esophageal cancer, stage IIIC esophageal cancer