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

NCT03238404 | Completed DMC

• 1 other identifier: BE2015687NAC
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

gastric cancer; neoadjuvant chemotherapy; enhanced recovery after surgery; gastrectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative length of stay

  Postoperative length of stay

  1 month

Secondary Outcomes (6)

• Postoperative complications

  2 months

• The time to first flatus

  1 week

• Time to semi-liquid diet

  2 weeks

• Total protein

  1 week

• Albumin

  1 week

Study Arms (2)

NAC group

EXPERIMENTAL

Patients will receive neoadjuvant chemotherapy (NAC) before the gastrectomy and ERAS.

Procedure: NAC group

Surgery alone group

ACTIVE COMPARATOR

Patients will not receive NAC before the gastrectomy and ERAS.

Procedure: Surgery alone group

Interventions

NAC group PROCEDURE

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.

NAC group

Surgery alone group PROCEDURE

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

Surgery alone group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• JIANG Zhi-Wei: lead

Study Sites (1)

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Zhi-Wei JIANG, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  PRINCIPAL INVESTIGATOR

• Jian ZHAO, Ph.D.

  Jinling Hospital, Medical School of Nanjing University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Research Institute of General Surgery

Model Details: This study is a single-center, parallel, open-label randomized controlled trial.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 3, 2017
• Study Start: August 1, 2015
• Primary Completion: August 10, 2016
• Study Completion: December 20, 2016
• Last Updated: August 3, 2017

Record last verified: 2017-08

Locations

CN (1)