Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fudan University | OTHER |
| Capital Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy. |
|
| 2 | No Intervention | No neoadjuvant chemotherapy and surgery and then adjuvant chemotherapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mFOLFOX | Drug | oxaliplatin 100mg/m2, CF 400mg/m2, 5-FU 2400 mg/m2 46hr civ |
|
| Measure | Description | Time Frame |
|---|---|---|
| 5 year overall survival | Jan 2008 to Dec 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Jan 2008 to Dec 2012 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiwen Wu, M.D. | Contact | 86-10-88196050 | wuaw@sina.com | |
| Jiafu Ji, M.D. | Contact | 86-10-88196048 | jiafuj@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiafu Ji, M.D. | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University School of Oncology | Beijing | Beijing Municipality | 100036 | China |
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |