clinical T1 gastric cancer without submucosal invasion
Conditions
Interventions
Endoscopic submucal dissection with or without surgical gastrectomy after histological findings.
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven differentiated adenocarcinoma by biopsy. A mixed case of undifferentiated components is not eligible. 2) Non-recurrence and single tumor. 3) Clinical T1 tumor without submucosal invasion. 4) Size of tumor is >2cm in a UL(-) case or ≤3cm in a UL(+) case. 5) One-piece resection is possible with ESD. 6) The possibility of stenosis after EMR is low. 7) Clinical N0/M0 by abdominal CT. 8) Aged 20 to 75 years old. 9) PS (ECOG) of 0 or 1. 10) No gastrectomy and endoscopic treatment for simultaneous or metachronous gastric cancer, and no reconstructive surgery of stomach tube for esophageal cancer. 11) No prior treatment of chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 12) Sufficient organ functions. 13) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Impossible to discontinue anticoagulant or antiplatelet medications. 2) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 3) Women during pregnancy or breast-feeding. 4) Psychosis. 5) Systemic steroids medication. 6) Active bacterial or fungous infection. 7) History of myocardial infarction or unstable angina pectoris within three months. 8) Uncontrollable hypertension. 9) Uncontrollable diabetes mellitus or administration of insulin. 10) Severe respiratory disease requiring continuous oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| OS in UL(-) cases, OS in UL(+) cases, recurrence-free survival (RFS), 5-year RFS with stomach, proportion of one-piece resection, proportion of pathological curative resection after EMR, adverse events, serious adverse events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Ono
JCOG0607 Coordinating Office Division of Endoscopy, Shizuoka Cancer Center
Outcome results
None listed