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

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

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

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: NAC group; Procedure: Surgery alone group

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Jinling Hospital, Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: JIANG Zhi-Wei

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 10, 2016
• Study Completion (Actual): December 20, 2016

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: neoadjuvant chemotherapy; gastric cancer; gastrectomy; enhanced recovery after surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: BE2015687NAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The results and IPD will be considered to share in published articles.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No