Status:
UNKNOWN
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
Lead Sponsor:
University of Toyama
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20-74 years
Phase:
NA
Brief Summary
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 al...
Detailed Description
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 concu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00766480
Start Date
January 1 2007
Last Update
August 26 2013
Active Locations (20)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
3
National Kyushu Cancer Center
Fukuoka, Fukuoka, Japan, 811-1395
4
Kurume University School of Medicine
Kurume, Fukuoka, Japan, 830-0011