Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|