Spots Global Cancer Trial Database for A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
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Trial Identification
Brief Title: A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
Official Title: A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
Study ID: NCT01291407
Study Description
Brief Summary: The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with radiation therapy for locally advanced or recurrent gastric cancer.
Detailed Description: This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to 80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent gastric cancer. Patients will be treated with external beam radiation therapy in a standard manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects (CTCAE)3.0.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC), Beijing, , China
Contact Details
Name: Jing Jin, MD,PhD
Affiliation: Department of Radiation Oncology,Cancer Hospital and Institute,CAMS
Role: PRINCIPAL_INVESTIGATOR
Name: Yexiong Li, MD,PhD
Affiliation: Department of Radiation Oncology,Cancer Hospital and Institute, CAMS
Role: PRINCIPAL_INVESTIGATOR
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