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The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy combined with HIPEC is superior to only radical gastrectomy in terms of overall survival.
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo neoadjuvant chemotherapy followed by radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive postoperative chemotherapy (6 circles together with neoadjuvant chemotherapy) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open and parallel group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without HIPEC | Sham Comparator | Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy) |
|
| With HIPEC | Experimental | Patients will be treated with neoadjuvant chemotherapy (SOX) followed by a D2 radical gastrectomy for locally advanced gastric cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (SOX, 6 circles together with neoadjuvant chemotherapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D2 radical gastrectomy | Procedure | radical gastrectomy with D2 lymphadenectomy |
|
| 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 |
|---|---|---|
| progression-free survival | 5 years | |
| distant metastasis rate | 5 years | |
| peritoneal metastasis rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan University | Recruiting | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004358 | Drug Therapy |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D006979 | Hyperthermia, Induced |
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| SOX neoadjuvant or postoperative chemotherapy | Drug | Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14. |
|
|
| Hyperthermic intraperitoneal chemotherapy (HIPEC) | Procedure | Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min. |
|
|
| 5 years |
| local recurrence rate | 5 years |
| complication rate | 5 years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |