Clinical trial NCT02902575: The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Official title: The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
Laparoscopy
Advanced Gastric Cancer
Neoadjuvant Chemotherapy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the safety, feasibility, long-term and oncologicaloutcomes of laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy.

Detailed description: A prospective single-arm study designed to further evaluate laparoscopic-assisted gastrectomy for advanced Gastric Cancer after neoadjuvant chemotherapy will be performed, to evaluate the safety, feasibility, long-term and oncological outcomes. The evaluation parameters are perioperative mobility and mortality, perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75 years
* Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
* cT2-4aN+M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* No distant metastasis is observed. And the spleen, pancreas or other adjacent organs are not involved by the tumor.
* Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
* American Society of Anesthesiology score (ASA) class I, II, or III
* Written informed consent

Exclusion Criteria:

* Women during pregnancy or breast-feeding
* Severe mental disorder
* History of previous upper abdominal surgery (except laparoscopic cholecystectomy, previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection)
* History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
* History of other malignant disease within past five years
* History of unstable angina or myocardial infarction within past six months
* History of cerebrovascular accident within past six months
* History of continuous systematic administration of corticosteroids within one month
* Requirement of simultaneous surgery for other disease
* Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
* FEV1\<50% of predicted values

Primary outcomes:
measure: Morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Pathological response
timeFrame: 30 days
measure: Radiological response
timeFrame: 30 days
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Mortality
timeFrame: 30 days
measure: Time to first ambulation
timeFrame: 10 days
measure: Rates of combined organ resection
timeFrame: 1 day
measure: The number of lymph node dissection
timeFrame: 1 day
measure: The variation of weight
timeFrame: 12 months
measure: The daily highest body temperature
timeFrame: 7 days
measure: Time to first flatus
timeFrame: 10 days
measure: Time to first liquid diet
timeFrame: 10 days
measure: Time to soft diet
timeFrame: 10 days
measure: Scale the amount of abdominal drainage
timeFrame: 10 days
measure: Blood transfusion
timeFrame: 10 days
measure: The number of positive lymph nodes
timeFrame: 1 days
measure: Intraoperative lymph node dissection time
timeFrame: 1 days
measure: Intraoperative blood loss
timeFrame: 1 days
measure: Time of operation
timeFrame: 1 day
measure: Intraoperative injury
timeFrame: 1 days
measure: The amount of use of titanium clip
timeFrame: 1 days
measure: The rate of conversion to laparotomy
timeFrame: 1 days
measure: The variation of albumin
timeFrame: 12 month
measure: The results of endoscopy
timeFrame: 12 month
measure: The values of white blood cell count
timeFrame: 7 days
measure: The values of hemoglobin
timeFrame: 7 days
measure: The values of C-reactive protein
timeFrame: 7 days
measure: The values of prealbumin
timeFrame: 7 days
measure: Duration of hospital stay
timeFrame: 10 days
measure: Late postoperative complication
timeFrame: 36 months
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: