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
NCT ID: NCT00766480
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Study Groups
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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.
cisplatin
Given IV
fluorouracil
Given IV
radiation therapy
Patients undergo radiotherapy
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.
cisplatin
Given IV
fluorouracil
Given IV
radiation therapy
Patients undergo radiotherapy
Interventions
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cisplatin
Given IV
fluorouracil
Given IV
radiation therapy
Patients undergo radiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
20 Years
74 Years
ALL
No
Sponsors
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University of Toyama
OTHER
Principal Investigators
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Yutaka Shimada, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toyama
Locations
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Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
National Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
Kurume University School of Medicine
Kurume, Fukuoka, Japan
Gunma University Graduate School of Medicine
Maebashi, Gunma, Japan
Hiroshima City Asa Hospital
Hiroshima, Hiroshima, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Kagoshima University
Kagoshima, Kagoshima-ken, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan
Niigata Cancer Center Hospital
Niigata, Niigata, Japan
Kawasaki Medical School
Kurashiki, Okayama-ken, Japan
Graduate School of Medical Science at the University of Ryukyu
Nishiharacho, Okinawa, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Osaka, Japan
Kinki University School of Medicine
Sayama, Osaka, Japan
Osaka University Graduate School of Medicine
Suita, Osaka, Japan
Mita Hospital at the International University of Health and Welfare
Tokyo, Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Tokyo, Japan
Toyama University Hospital
Toyama, Toyama, Japan
Countries
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Facility Contacts
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Shunzo Hatooka
Role: primary
Keiko Minashi
Role: primary
Yasushi Toh, MD, PhD
Role: primary
Toshiaki Tanaka
Role: primary
Hiroyuki Kuwano, MD, PhD
Role: primary
Hidenori Mukaida
Role: primary
Koushi Oh
Role: primary
Kenichiro Ikeda
Role: primary
Shoji Natsugoe
Role: primary
Michihide Mitsumori
Role: primary
Tatsuo Kanda, MD
Role: primary
Hiroshi Yabusaki
Role: primary
Toshihiro Hirai
Role: primary
Tadashi Nishimaki
Role: primary
Ryu Ishihara
Role: primary
Takushi Yasuda
Role: primary
Masaichi Ohira
Role: primary
Ken-ichi Mafune, MD
Role: primary
Tsutomu Nakamura
Role: primary
Yutaka Shimada, MD, PhD
Role: primary
Other Identifiers
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TOYAMAU-TRIEC0601
Identifier Type: -
Identifier Source: secondary_id
CDR0000615602
Identifier Type: -
Identifier Source: org_study_id