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The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D2 lymphadenectomy and HIPEC and Systemic chemotherapy | Experimental | Intraoperative and postoperative hyperthermic intraperitoneal chemotherapy (twice HIPEC) were performed after radical gastrectomy with D2 lymphadenectomy, followed by 8 cycles of systemic chemotherapy. HIPEC was conducted within 48 h after surgery: Normal saline 3000ml-4000ml, Paclitaxel 75mg/m^2, 43°C, 60min. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. |
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| D2 lymphadenectomy+Systemic chemotherapy | Placebo Comparator | 8 cycles of systemic chemotherapy were performed after radical gastrectomy with D2 lymphadenectomy. Systemic chemotherapy (XELOX): Oxaliplatin: 130mg/m^2, d1, Intravenous infusion, every 3 weeks. Capecitabine: 1g/m^2 bid, days 1-14, every 3 weeks and maximum 8 cycles, or progression/intolerance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 lymphadenectomy | Procedure | The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of surgery to the date of death or to the end of follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival | From the date of surgery to the date of recurrence or to the end of follow-up | 5 years |
| Locoregional-free survival | From the date of surgery to the date of locoregional recurrence or to the end of follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhiyuan fang, Ph.D | Contact | 86020666736662012 | fangjnu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| shuzhong cui, Ph.D | Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510095 | China |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D017024 | Chemotherapy, Adjuvant |
| D004358 | Drug Therapy |
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| Systemic chemotherapy | Procedure |
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| HIPEC | Procedure |
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| 5 years |
| Hepatic metastases-free survival | From the date of surgery to the date of recurrence or to the end of follow-up | 5 years |
| D006979 |
| Hyperthermia, Induced |