Gastric cancer
Conditions
Interventions
* Less-intensive surveillance
The following examinations are performed for 5 years after surgery at the intervals specified below:
(1) Physical examination, medical interview, and blood tests (periphe
Sponsors
YOSHIKAWA Takaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Pathologically proven adenocarcinoma of the stomach. (2) Tumor mainly located in the stomach (upper, middle, or lower third) or the esophagogastric junction, without esophageal invasion of > 2 cm. (3) Gastrectomy with systematic lymph node dissection (D1+ or D2), including total gastrectomy, distal gastrectomy, pylorus-preserving gastrectomy, proximal gastrectomy, or subtotal gastrectomy, was performed. Open, laparoscopic, and robot-assisted approaches are permitted. Additional surgical resection after endoscopic resection (endoscopic mucosal resection or endoscopic submucosal dissection) is allowed if performed within 91 days after the endoscopic procedure. (4) R0 resection was performed. (5) No distant metastasis was detected by preoperative chest and abdominal contrast-enhanced CT or FDG-PET/CT. (6) Both preoperative tumor marker levels, CEA and CA19-9, are within the normal ranges. (7) Diagnosed as pathological stage I according to the Japanese Classification of Gastric Carcinoma (15th edition). (8) Within 42 days after surgery. (9) Age 20 to 80 years. (10) ECOG performance status 0-1. (11) Body mass index < 30 kg/m2. (12) No prior chemotherapy or radiotherapy to the abdomen or pelvis for any malignancy, except for postoperative adjuvant chemotherapy after curative resection. (13) Written informed consent.
Exclusion criteria
Exclusion criteria: (1) Simultaneous or metachronous (within five years) double cancers, with the exception of intramucosal tumor curable with local therapy. (2) Active infection requiring systemic therapy. (3) Psychological disorder difficult to participate in this clinical trial. (4) Receiving continuous systemic corticosteroid or immunosuppressant treatment. (5) History of unstable angina pectoris within three weeks or myocardial infarction within 6 months before the enrollment. (6) Uncontrolled arterial hypertension. (7) Diabetes mellitus with poor control or requiring continuous insulin therapy. (8) Clinically diagnosed liver cirrhosis classified as Child-Pugh class B or C. (9) Chronic renal failure requiring maintenance dialysis. (10) Respiratory disease requiring continuous oxygen therapy. (11) Requirement for routine chest, abdominal and/or pelvic CT at least once per year due to pre-existing medical conditions or comorbidities. (12) Anticipated to require frequent outpatient visits or hospitalization after registration for the management or follow-up of perioperative complications related to gastrectomy. (13) Anticipated to require frequent outpatient visits after registration due to post-gastrectomy syndromes (e.g., poor oral intake, reflux symptoms, stenosis-related symptoms, or dumping syndrome).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival, disease-free survival, disease-specific survival, the proportion of resectable recurrent disease, the total number of hospital visits, the number of examinations, frequency of adverse events | — |
Contacts
Public ContactTsutomu Hayashi
National Cancer Center Hospital
Outcome results
None listed