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
Conditions
Esophageal Cancer
Conditions: official terms
Carcinoma, Squamous Cell - Esophageal Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
N/A
Study Design
Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cisplatin Type: Drug
Name: fluorouracil Type: Drug
Name: radiation therapy Type: Radiation
Overall Status
Recruiting
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 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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 20 Years
Gender: Both
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
Locations
Aichi Cancer Center
Nagoya, Aichi, Japan
Status: Recruiting
Contact: Shunzo Hatooka - 81-52-762-6111
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Status: Recruiting
Contact: Keiko Minashi - 81-4-7133-1111
Kurume University School of Medicine
Kurume, Fukuoka, Japan
Status: Recruiting
Contact: Toshiaki Tanaka - 81-942-35-3311
Gunma University Graduate School of Medicine
Maebashi-shi, Gunma, Japan
Status: Recruiting
Contact: Hiroyuki Kuwano, MD, PhD - 81-27-220-8224 - hkuwano@med.gunma-u.ac.jp
Hyogo College of Medicine
Nishinomiya, Hyogo, Japan
Status: Recruiting
Contact: Koushi Oh - 81-798-45-6582
Iwate Medical University Hospital
Morioka, Iwate, Japan
Status: Recruiting
Contact: Kenichiro Ikeda - 81-19-651-5111
Kawasaki Medical School
Kurashiki, Okayama, Japan
Status: Recruiting
Contact: Toshihiro Hirai - 81-86-462-1199
Graduate School of Medical Science at the University of Ryukyu
Nishiharacho, Okinawa, Japan
Status: Recruiting
Contact: Tadashi Nishimaki - 81-98-895-3331
Kinki University School of Medicine
Osakasayama, Osaka, Japan
Status: Recruiting
Contact: Takushi Yasuda - 81-72-366-0221
Osaka University Graduate School of Medicine
Suita, Osaka, Japan
Status: Recruiting
Contact: Masaichi Ohira - 81-6-6645-3837
National Kyushu Cancer Center
Fukuoka, Japan
Status: Recruiting
Contact: Yasushi Toh, MD, PhD - 81-92-541-3231
Hiroshima City Asa Hospital
Hiroshima, Japan
Status: Recruiting
Contact: Hidenori Mukaida - 81-82-815-5211
Kagoshima University
Kagoshima, Japan
Status: Recruiting
Contact: Shoji Natsugoe - 81-99-275-5361
Kyoto University Hospital
Kyoto, Japan
Status: Recruiting
Contact: Michihide Mitsumori - 81-75-751-3417
Niigata Cancer Center Hospital
Niigata, Japan
Status: Recruiting
Contact: Hiroshi Yabusaki - 81-25-266-5111
Niigata University Medical and Dental Hospital
Niigata, Japan
Status: Recruiting
Contact: Tatsuo Kanda, MD - 81-25-227-2228
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan
Status: Recruiting
Contact: Ryu Ishihara - 81-6-6972-1181
Mita Hospital at the International University of Health and Welfare
Tokyo, Japan
Status: Recruiting
Contact: Ken-ichi Mafune, MD - 81-3-3451-8121 - mafune@iuhw.ac.jp
Tokyo Women's Medical University
Tokyo, Japan
Status: Recruiting
Contact: Tsutomu Nakamura - 81-3-3353-8111
Toyama University Hospital
Toyama, Japan
Status: Recruiting
Contact: Yutaka Shimada, MD, PhD - 81-76-434-7331
Start Date
January 2007
Sponsors
Toyama University Hospital
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page