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| Name | Class |
|---|---|
| Xijing Hospital | OTHER |
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Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 pre-operative chemoradiation | Experimental | Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2 |
|
| Arm 2 post operative chemoradiation | Active Comparator | Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 pre-operative chemoradiation | Other | Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | up to 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | up to 5 year | |
| R0 Resection Rate | At time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Peng, MD PhD | Contact | 008617708130617 | pengqian0522@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zeng, MD PhD | Sichuan Academy of Medical Science | Study Chair |
| Hongwei Zhang, MD PhD | Xijing Hosptial, GI institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital, GI institute | Active, not recruiting | Xi’an | Shanxi | 710032 | China | |
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| Arm 2 post operative chemoradiation | Other | Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29 |
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| friendship Hospital |
| Recruiting |
| Chengdu |
| Sichuan |
| 610000 |
| China |
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| ziyang People's Hospital | Recruiting | Siyang | Sichuan | China |
|