Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
|ClinicalTrials.gov Identifier: NCT00591045|
Recruitment Status : Unknown
Verified December 2007 by Peking University.
Recruitment status was: Not yet recruiting
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Stomach Neoplasms Gastric Cancer||Drug: mFOLFOX||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||263 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||January 2008|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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.
- 5 year overall survival [ Time Frame: Jan 2008 to Dec 2012 ]
- R0 resection rate [ Time Frame: Jan 2008 to Dec 2012 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|