An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
20 Years
74 Years
Both
Esophageal Cancer
Trial Information
An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1-year progression-free survival
Safety Issue:
No
Principal Investigator
Yutaka Shimada, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Toyama University Hospital
Authority:
Unspecified
Study ID:
CDR0000615602
NCT ID:
NCT00766480
Start Date:
January 2007
Completion Date:
Related Keywords:
- Esophageal Cancer
- squamous cell carcinoma of the esophagus
- stage II esophageal cancer
- stage III esophageal cancer
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Diseases
- Esophageal Neoplasms
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