Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy

Study Overview
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Brief Summary
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Patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (ERAS) programs.

Detailed Description
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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.

Official Title
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The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: NAC group
* Procedure: Surgery alone group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with locally advanced gastric cancer. Age older than 18 and younger than 75 years. American Society of Anesthesiologists (ASA) class: I-III. Participants can describe the symptom objectively and cooperate actively. Written informed consent Exclusion Criteria: Patients allergic to oxaliplatin, tegafur gimerac etc. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA) Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min). Patients who require simultaneous surgery for other diseases. Patients who received upper abdominal surgery previously. Pregnant or breast-feeding women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a single-center, parallel, open-label randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC group<br>Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS. | Procedure: NAC group<br>* 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.<br>|
| Active Comparator: Surgery alone group<br>Patients will not receive NAC before the gastrectomy and ERAS. | Procedure: Surgery alone group<br>* Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative length of stay | Postoperative length of stay | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications | 2 months | 
| The time to first flatus | Bowel recovery | 1 week | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, neoadjuvant chemotherapy, enhanced recovery after surgery, gastrectomy