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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238404
• Other study ID #: BE2015687NAC
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: August 2, 2017
• Start date: August 1, 2015
• Est. completion date: December 20, 2016

Study information

• Verified date: August 2017
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 20, 2016
• Est. primary completion date: August 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• NAC group
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 group
Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.

Locations

Country	Name	City	State
China	Jinling Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
JIANG Zhi-Wei

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative length of stay	Postoperative length of stay	1 month
Secondary	Postoperative complications	Postoperative complications	2 months
Secondary	The time to first flatus	Bowel recovery	1 week
Secondary	Time to semi-liquid diet	Bowel recovery	2 weeks
Secondary	Total protein	Nutritional status	1 week
Secondary	Albumin	Nutritional status	1 week
Secondary	Prealbumin	Nutritional status	1 week