Trial | NCT00766480  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
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.
Study Started
Jan 31
2007
Primary Completion
Mar 31
2010
Anticipated
Last Update
Aug 26
2013
Estimate

Drug cisplatin

Given IV

Drug fluorouracil

Given IV

Radiation radiation therapy

Patients undergo radiotherapy

Regimen 1 Experimental

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 Experimental

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.

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
No Results Posted