Spots Global Cancer Trial Database for Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
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Trial Identification
Brief Title: Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Official Title: A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Study ID: NCT00591045
Interventions
Study Description
Brief Summary: This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer. Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.
Detailed Description: The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.
Eligibility
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Peking University School of Oncology, Beijing, Beijing, China
Contact Details
Name: Jiafu Ji, M.D.
Affiliation: Peking University
Role: PRINCIPAL_INVESTIGATOR
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