Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer|
- 5 year overall survival [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]
- R0 resection rate [ Time Frame: Jan 2008 to Dec 2012 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ
No Intervention: 2
No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591045
|Contact: Aiwen Wu, M.D.||firstname.lastname@example.org|
|Contact: Jiafu Ji, M.D.||email@example.com|
|Peking University School of Oncology||Not yet recruiting|
|Beijing, Beijing, China, 100036|
|Contact: Jiafu Ji, M.D. 86-10-88196048 firstname.lastname@example.org|
|Principal Investigator: Jiafu Ji, M.D.|
|Principal Investigator:||Jiafu Ji, M.D.||Peking University|