Gastric Cancer
Conditions
Interventions
Laparoscopic Surgry:Laparoscopic radical gastrectomy
Open Surgery:Open radical gastrectomy
Sponsors
Peking University Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Ambulatory male or female aged 70 and above; 2. Karnofsky score=70%; 3. 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; 4. No past chemotherapy or radiotherapy before diagnosis; 5. Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) via distal subtotal or total gastrectomy plus lymphadenectomy; 6. Haematology and biochemistry index meet the following: hemoglobin=80g/L, absolute neutrophils count (ANC)=1.5×109/L, platelet=100×109/L, ALTAST=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; 7. No severe concomitant disease that leads to survival<3 years; 8. Willing and able to comply with study protocol; 9. Written agreement consent before enrolment and full aware of the right to quit the study at any time with no loss.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled seizure, central nervous system diseases, or mental disorders; 2. Past history of upper abdominal surgery (except for laparoscopic cholecystectomy); 3. Past history of gastric surgery (including diagnosis procedure such as ESD and EMR); 4. Other malignant diseases in 5 years (except for cured skin carcinoma and cervical carcinoma in situ); 5. 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; 6. Cerebral hemorrhage or infarction in 6 months; 7. Organ transplant recipients under immunosuppressive therapy; 8. Severe uncontrolled repeated infection or other severe uncontrolled concomitant diseases; 9. Medium or severe renal damage (creatinine clearance rate=50ml/min or serum creatinine> upper limit of normal value); 10. Other diseases requiring synchronous surgery; 11. Requiring emergent surgery due to oncologic emergent (e.g. bleeding, perforation, obstruction); 12. FEV1<50% of expected value; 13. Participated in other studies 4 weeks before the randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complication rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rreadmission rate;Postoperative hospitalization stay;One-year postoperative life quality;Three-year overall survival;Three-year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactZiyu Li
Peking University Cancer Hospital & Institute
Outcome results
None listed