Spots Global Cancer Trial Database for 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
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Trial Identification
Brief 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
Official Title: An Investigational Study of Chemoradiosensitivity Prediction With Genetic Profiling of Esophageal Biopsy for Squamous Cell Carcinoma of the Esophagus
Study ID: NCT00766480
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aichi Cancer Center, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kurume University School of Medicine, Kurume, Fukuoka, Japan
Gunma University Graduate School of Medicine, Maebashi-shi, Gunma, Japan
Hyogo College of Medicine, Nishinomiya, Hyogo, Japan
Iwate Medical University Hospital, Morioka, Iwate, Japan
Kawasaki Medical School, Kurashiki, Okayama, Japan
Graduate School of Medical Science at the University of Ryukyu, Nishiharacho, Okinawa, Japan
Kinki University School of Medicine, Osakasayama, Osaka, Japan
Osaka University Graduate School of Medicine, Suita, Osaka, Japan
National Kyushu Cancer Center, Fukuoka, , Japan
Hiroshima City Asa Hospital, Hiroshima, , Japan
Kagoshima University, Kagoshima, , Japan
Kyoto University Hospital, Kyoto, , Japan
Niigata University Medical and Dental Hospital, Niigata, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Mita Hospital at the International University of Health and Welfare, Tokyo, , Japan
Tokyo Women's Medical University, Tokyo, , Japan
Toyama University Hospital, Toyama, , Japan
Contact Details
Name: Yutaka Shimada, MD, PhD
Affiliation: University of Toyama
Role: PRINCIPAL_INVESTIGATOR
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