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Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.
In recent years, enhanced recovery after surgery (ERAS) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as China and Japan, confirming that ERAS programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. However, in most studies on ERAS for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. Investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC group | Experimental | Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS. |
|
| Surgery alone group | Active Comparator | Patients will not receive NAC before the gastrectomy and ERAS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAC group | Procedure | NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative length of stay | Postoperative length of stay | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Postoperative complications | 2 months |
| The time to first flatus | Bowel recovery | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-Wei JIANG, Ph.D. | Jinling Hospital, Medical School of Nanjing University | Principal Investigator |
| Jian ZHAO, Ph.D. | Jinling Hospital, Medical School of Nanjing University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | 210002 | China |
The results and IPD will be considered to share in published articles.
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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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This study is a single-center, parallel, open-label randomized controlled trial.
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|
| Surgery alone group | Procedure | Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone. |
|
| Time to semi-liquid diet | Bowel recovery | 2 weeks |
| Total protein | Nutritional status | 1 week |
| Albumin | Nutritional status | 1 week |
| Prealbumin | Nutritional status | 1 week |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |