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Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.
The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).
The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| without HIPEC | No Intervention | Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and postoperative chemotherapy (SOX or XELOX). | |
| with HIPEC | Experimental | Patients will be treated with a D2 radical gastrectomy for advanced gastric cancer and intraperitoneal chemoperfusion with cisplatin and postoperative chemotherapy as described for the control group. Cisplatin: 75mg/m2 (max 150mg/m2 max 5L ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraperitoneal chemoperfusion | Procedure | HIPEC with cisplatin at the time of D2 radical surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | overall survival [ Time Frame: Death or 2 years ] | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| complication rate | 30 days | |
| time to progress | follow up every 3 months till 24 months end of study | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Wang | Contact | 86-13815890469 | wangmeng001@263.net | |
| Wenxian Guan | Contact | 86-83106666-60931 | guan_wx@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenxian Guan | China Health Ministry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meng Wang | Recruiting | Nanjing | Jiangsu | 210000 | 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 |
|---|---|
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| time to distant metastasis |
time to other distant metastases follow up every 3 months till 24 months |
| 24 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006979 |
| Hyperthermia, Induced |