cT3(SS) or cT4a(SE) gastric cancer
Conditions
Interventions
A:omentectomy
B:omentum preservation
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st inclusion criteria (before surgery) 1)Histologically proven gastric adenocarcinoma. 2)Clinical T3/T4 by imaging. 3)cN0-3b H0 P0 M0 and not bulky N2 by contrast-enhanced abdominal computed tomography. 4)Both of HER2 positive and negative patients. HER2 negative has to be confirmed in patients with enlarged lymph node above 15mm in minor axis. 5)Expected R0 surgery 6)Neither Borrmann type 4 nor large (>8cm) type 3 7)Length of esophageal invasion not exceeding 3cm 8)Not stump cancer of stomach 9)Aged between 20 and 79 years old 10)Eastern Cooperative Oncology Group performance status of 0 or 1. 11)No history of upper abdominal surgery or intestinal resection 12)No prior chemotherapy, radiotherapy, or endocrine therapy for any malignancies 13)Adequate organ functions defined as indicated below; i) WBC of 3,000/mm3 or more ii) Platelet is 100,000/mm3 or more iii) T.Bil of 2.0 mg/dL or less iv) AST of 100 IU/L or less v) ALT of 100 IU/L or less vi) Creatinine of 1.5 mg/dL or less 14) Written informed consent 2nd inclusion criteria (during surgery) 1)cT3(SS) or cT4a(SE) 2)cN0-3b H0 P0 M0 3)Expected R0 or R1 only by CY1 4)No need of thoracotomy for resection 5)Expected total resection of omentum
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days of postparturition, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 9) HIV antibody positive 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, blood loss, operation time, adverse events | — |
Countries
Japan
Contacts
Public ContactTakanobu Yamada
JCOG1711 Coordinating Office Department of Gastrointestinal Surgery, Kanagawa Cancer Center
Outcome results
None listed