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Completed

NCT Number: NCT03238404

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Surgery alone group

Procedure

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

Primary outcomes

  1. Postoperative length of stay

    Time frame: 1 month

    Postoperative length of stay

Secondary outcomes

  1. Postoperative complications

    Time frame: 2 months

    Postoperative complications

  2. The time to first flatus

    Time frame: 1 week

    Bowel recovery

  3. Time to semi-liquid diet

    Time frame: 2 weeks

    Bowel recovery

  4. Total protein

    Time frame: 1 week

    Nutritional status

  5. Albumin

    Time frame: 1 week

    Nutritional status

  6. Prealbumin

    Time frame: 1 week

    Nutritional status

Sponsors and collaborators

Lead sponsor

JIANG Zhi-Wei

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2017
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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