Phase
Condition
Gastric Cancer
Stomach Cancer
Digestive System Neoplasms
Treatment
N/AClinical Study ID
Ages > 70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ambulatory male or female aged 70 and above
Karnofsky score≥70%
Histologically proven gastric adenocarcinoma in biopsy (including Laurenclassification) Proven clinical stage of cT2-4aNanyM0 by baseline ultrasoundendoscope, enhanced CT/MRI examination, or diagnostic laparoscopy using HabermannStandards
No past chemotherapy or radiotherapy before diagnosis
Primary tumor located at stomach, achievable naked-eye complete resection (R0/1) viadistal subtotal or total gastrectomy plus lymphadenectomy
Haematology and biochemistry index meet the following: hemoglobin≥80g/L, absoluteneutrophils count (ANC)≥1.5×109/L, platelet≥100×109/L, ALT、AST≤2.5 times the upperlimit of normal value, ALP≤2.5 times the upper limit of normal value, serum totalbilirubin<1.5 times the upper limit of normal value, serum creatinine<1 times theupper 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 beforeenrolment and full aware of the right to quit the study at any time with no loss
Exclusion
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 cervicalcarcinoma 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 myocardialinfarction in 6 months
Cerebral hemorrhage or infarction in 6 months
Organ transplant recipients under immunosuppressive therapy
Severe uncontrolled repeated infection or other severe uncontrolled concomitantdiseases
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 therandomization.
Study Design
Study Description
Connect with a study center
Peking University Cancer Hospital & Institute
Beijing, Beijing 100142
ChinaActive - Recruiting

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