cT3(SS) or cT4a(SE) gastric cancer
Conditions
Interventions
A: non-bursectomy
B: bursectomy
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1st inclusion criteria (before surgery) 1) Histologically proven primary gastric adenocarcinoma 2) cT3(SS)-T4b(SI) 3) cN0-2 H0 P0 M0 and not bulky N2 4) Possible for R0 surgery 5) Not Borrmann type 4 and not large (8cm or less) type 3 6) Length of esophageal invasion less or equal to 3cm 7) Not stump cancer of stomach 8) No history of upper abdominal surgery and no history of intestinal resection 9) No prior treatment of chemotherapy or radiation therapy against any other malignancies 10) Aed 20 to 80 years old 11) PS(ECOG) of 0 or 1 12) Body mass index is less than 30 13) Adequate organ functions defined as indicated below; i) WBC is 3,000/mm3 or more ii) Platelet is 100,000/mm3 or more iii) AST is 100 IU/L or less iv) ALT is 100 IU/L or less v) T.Bil is 2.0 mg/dL or less vi) Cr is 1.5 mg/dL or less 14) Written informed consent from patient 2nd inclusion criteria (during surgery) 1) cT3(SS) or cT4a(SE) 2) cN0-2 H0 P0 M0 3) Possible for R0 or R1 suregry due to only CY1 4) No need of thoracotomy for resection 5) Possible for bursectomy
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Infectious disease with systemic therapy indicated 3) Body temperature is higher than 38 degrees centigrade 4) Women during pregnancy or breast-feeding 5) Severe mental disease 6) Continuous systemic steroid therapy 7) Unstable angina pectoris or history of myocardial infarction within 6 months 8) Uncontrollable hypertension 9) Uncontrollable diabetes millutus or administration of insulin 10) Severe respiratory disease requiring continuous oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, blood loss, operation time, surgical complications, adverse events of adjuvant chemotherapy | — |
Countries
Japan
Contacts
Public ContactYukinori Kurokawa
JCOG1001 Coordinating Office Osaka University Graduate School of Medicine, Department of Gastroenterological Surgery
Outcome results
None listed