Clinical trial NCT03238404: Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in ERAS Programs for Radical Gastrectomy
Official title: The Application of Neoadjuvant Chemotherapy for Patients With Advanced Gastric Cancer in Enhanced Recovery After Surgery Programs for Radical Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: gastric cancer
neoadjuvant chemotherapy
enhanced recovery after surgery
gastrectomy
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a single-center, parallel, open-label randomized controlled trial.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay
timeFrame: 1 month
Secondary outcomes:
measure: Postoperative complications
timeFrame: 2 months
measure: The time to first flatus
timeFrame: 1 week
measure: Time to semi-liquid diet
timeFrame: 2 weeks
measure: Total protein
timeFrame: 1 week
measure: Albumin
timeFrame: 1 week
measure: Prealbumin
timeFrame: 1 week
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Zhi-Wei JIANG, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinling Hospital, Medical School of Nanjing University
name: Jian ZHAO, Ph.D.
role: STUDY_DIRECTOR
References: