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

Not Applicable

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT03238404
• Lead Sponsor: JIANG Zhi-Wei

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-08-10
• Study Completion: 2016-12-20
• Study First Submitted: 2017-07-27
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-03
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1. Patients with locally advanced gastric cancer.
2. Age older than 18 and younger than 75 years.
3. American Society of Anesthesiologists (ASA) class: I-III.
4. Participants can describe the symptom objectively and cooperate actively.
5. Written informed consent

Exclusion Criteria

1. Patients allergic to oxaliplatin, tegafur gimerac etc.
2. Patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function > II (NYHA)
3. Patients with complications (bleeding, perforation and obstruction) caused by gastric cancer.
4. Patients with severe liver and renal dysfunction (Child - Pugh ≥ 10; Cr < 25 ml/min).
5. Patients who require simultaneous surgery for other diseases.
6. Patients who received upper abdominal surgery previously.
7. Pregnant or breast-feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay	1 month	Postoperative length of stay

Secondary Outcome Measures

Name	Time	Method
Total protein	1 week	Nutritional status
Albumin	1 week	Nutritional status
Time to semi-liquid diet	2 weeks	Bowel recovery
Postoperative complications	2 months	Postoperative complications
The time to first flatus	1 week	Bowel recovery
Prealbumin	1 week	Nutritional status

Trial Locations

Locations (1)

Jinling Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China