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| ID | Type | Description | Link |
|---|---|---|---|
| TOYAMAU-TRIEC0601 |
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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:
OUTLINE: Patients receive 1 of the following treatment regimens:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
| |
| fluorouracil |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year progression-free survival | ||
| 1-year local progression-free survival | ||
| 3-year progression-free survival | ||
| 3-year overall survival | ||
| Complete histological response |
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DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma of the thoracic esophagus
No tumor extension to the cervical esophagus or cardia of the stomach
No multiple and different histological types of cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Yutaka Shimada, MD, PhD | University of Toyama | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Recruiting | Nagoya | Aichi-ken | 464-8681 | Japan |
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| Drug |
Given IV |
|
| radiation therapy | Radiation | Patients undergo radiotherapy |
|
| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
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| National Kyushu Cancer Center | Recruiting | Fukuoka | Fukuoka | 811-1395 | Japan |
|
| Kurume University School of Medicine | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
|
| Gunma University Graduate School of Medicine | Recruiting | Maebashi | Gunma | 371-8511 | Japan |
|
| Hiroshima City Asa Hospital | Recruiting | Hiroshima | Hiroshima | 731-0293 | Japan |
|
| Hyogo College of Medicine | Recruiting | Nishinomiya | Hyōgo | 663-8501 | Japan |
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| Iwate Medical University Hospital | Recruiting | Morioka | Iwate | 020-8505 | Japan |
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| Kagoshima University | Recruiting | Kagoshima | Kagoshima-ken | 890-8520 | Japan |
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| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | 606-8507 | Japan |
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| Niigata University Medical and Dental Hospital | Recruiting | Niigata | Niigata | 951-8510 | Japan |
|
| Niigata Cancer Center Hospital | Recruiting | Niigata | Niigata | 951-8566 | Japan |
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| Kawasaki Medical School | Recruiting | Kurashiki | Okayama-ken | 701-01 | Japan |
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| Graduate School of Medical Science at the University of Ryukyu | Recruiting | Nishiharacho | Okinawa | 903-0215 | Japan |
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| Osaka Medical Center for Cancer and Cardiovascular Diseases | Recruiting | Osaka | Osaka | 537-8511 | Japan |
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| Kinki University School of Medicine | Recruiting | Sayama | Osaka | 589-8511 | Japan |
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| Osaka University Graduate School of Medicine | Recruiting | Suita | Osaka | 565-0871 | Japan |
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| Mita Hospital at the International University of Health and Welfare | Recruiting | Tokyo | Tokyo | 108-8329 | Japan |
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| Tokyo Women's Medical University | Recruiting | Tokyo | Tokyo | 162-8666 | Japan |
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| Toyama University Hospital | Recruiting | Toyama | Toyama | 930-8555 | Japan |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |
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