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

JIANG Zhi-Wei88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer

Interventions

NAC groupPROCEDURE

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.

Surgery alone groupPROCEDURE

Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Postoperative length of stay

Time frame: 1 month

Secondary Outcomes

Postoperative complications

Time frame: 2 months

The time to first flatus

Bowel recovery

Time frame: 1 week

Time to semi-liquid diet

Bowel recovery

Time frame: 2 weeks

Total protein

Nutritional status

Time frame: 1 week

Albumin

Nutritional status

Time frame: 1 week

Prealbumin

Nutritional status

Time frame: 1 week

Data from ClinicalTrials.gov

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