Clinical trial NCT03564834: Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients
Official title: Laparoscopic Versus Open Gastrectomy for Elderly Local Advanced Gastric Cancer Patients: a Phase II Randomized Parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Gastric Cancer
Keywords: Elderly patients
Open gastrectomy
Laparoscopic gastrectomy
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 180
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gastric cancer is one of the most common malignant tumors worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer is increasing. Surgery is the essential treatment for local advanced gastric cancer. However, because of the degeneration of physiological organs, cell functions, compensatory ability, immunity, and physiological reserve ability, elderly patients often face great safety issues when having surgery. Therefore, how to treat the elderly patients with local advanced gastric cancer with safe and effective surgery is one of the important problems in the field of gastric cancer treatment. With the introduction of minimally invasive treatment concepts and techniques, the role of laparoscopic radical gastrectomy in the treatment of early gastric cancer, as well as the advantages of trauma control and postoperative accelerated rehabilitation have been confirmed, however, there is still a lack of sufficient high-level clinical evidence in the elderly patients with advanced gastric cancer. The current study therefore aims to evaluate the safety and efficacy of laparoscopic versus open gastrectomy for advanced gastric cancer in elderly patients, using a randomized parallel controlled study design. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.

Detailed description: Gastric cancer is one of the most common cancer and cause of cancer death worldwide. With the rapid aging of global population, the number of elderly patients with local advanced gastric cancer has been continuously increasing. Surgery is the essential treatment for local advanced gastric cancer. However, elderly patients are at high risk of postoperative complications due to reduced functional reserve and increased comorbidities. Studies have shown that elder patients can have postoperative complication incidence up to 18%-32% and surgery-related mortality rate to 3.8%-9.5%. Therefore, elderly patients usually require more restrict operative injury control compared to the younger population. Surgical safety and effectiveness has become a crucial research focus for local advanced gastric cancer among elderly patients.

Laparoscopic gastrectomy is one of the standard treatments for early gastric cancer and has demonstrated its application value in local advanced gastric cancer. Two recent meta-analysis on observational studies have shown the feasibility of laparoscopic gastrectomy in elderly gastric cancer patients. Compared to conventional open resections, elderly patients may benefit from the advantages of laparoscopic approach such as less trauma, less blood loss, faster bowel movement recovery, earlier food intake, and shorter hospitalization. However, laparoscopic gastrectomy raises issues such as prolonged operation time and disturbance of circulatory and respiratory dynamics by carbon dioxide pneumoperitoneum during the procedure. Nonetheless, all currently available evidence comes from observational studies that are susceptible to bias and evidence on long-term survival is scarce. The investigators therefore proposed to conduct this randomized controlled trial comparing the feasibility and survival benefit of laparoscopic with open gastrectomy for elderly patients with local advanced gastric cancer. The investigators hypothesized that laparoscopic gastrectomy is superior to open gastrectomy in terms of perioperative safety for local advanced gastric cancer patients aged 70 and above.

Eligibility criteria: Inclusion Criteria:

* Ambulatory male or female aged 70 and above
* Karnofsky score≥70%
* Histologically proven gastric adenocarcinoma in biopsy (including Lauren classification) Proven clinical stage of cT2-4aNanyM0 by baseline ultrasound endoscope, enhanced CT/MRI examination, or diagnostic laparoscopy using Habermann Standards
* No past chemotherapy or radiotherapy before diagnosis
* Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) via distal subtotal or total gastrectomy plus lymphadenectomy
* Haematology and biochemistry index meet the following: hemoglobin≥80g/L, absolute neutrophils count (ANC)≥1.5×109/L, platelet≥100×109/L, ALT、AST≤2.5 times the upper limit of normal value, ALP≤2.5 times the upper limit of normal value, serum total bilirubin\<1.5 times the upper limit of normal value, serum creatinine\<1 times the upper limit of normal value, serum albumin≥30g/L
* Heart and lung function can withstand surgery
* No severe concomitant disease that leads to survival\<3 years
* Willing and able to comply with study protocol Written agreement consent before enrolment and full aware of the right to quit the study at any time with no loss

Exclusion Criteria:

* Uncontrolled seizure, central nervous system diseases, or mental disorders;
* Past history of upper abdominal surgery (except for laparoscopic cholecystectomy)
* Past history of gastric surgery (including diagnosis procedure such as ESD and EMR)
* Other malignant diseases in 5 years (except for cured skin carcinoma and cervical carcinoma in situ)
* Clinical severe or active heart diseases, such as symptomatic coronary heart disease, NYHA grade II or above congestive heart failure, severe arrhythmia, or myocardial infarction in 6 months
* Cerebral hemorrhage or infarction in 6 months
* Organ transplant recipients under immunosuppressive therapy
* Severe uncontrolled repeated infection or other severe uncontrolled concomitant diseases
* Medium or severe renal damage (creatinine clearance rate≤50ml/min or serum creatinine\> upper limit of normal value)
* Other diseases requiring synchronous surgery
* Requiring emergent surgery due to oncologic emergent (e.g. bleeding, perforation, obstruction)
* FEV1\<50% of expected value Participated in other studies 4 weeks before the randomization.

Primary outcomes:
measure: Postoperative complication rate
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Length of postoperative hospitalization stay
timeFrame: within 30 days after surgery
measure: Postoperative life quality
timeFrame: one-year after surgery
measure: Three-year overall survival rate
timeFrame: Three-year after surgery
measure: Three-year disease-free survival rate
timeFrame: Three-year after surgery
measure: Postoperative pain
timeFrame: within 2 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital and Institute
name: Ziyu Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Z, Shan F, Ying X, Xue K, Ji J. Laparoscopic versus open gastrectomy for elderly local advanced gastric cancer patients: study protocol of a phase II randomized controlled trial. BMC Cancer. 2018 Nov 16;18(1):1118. doi: 10.1186/s12885-018-5041-y.