Type 4 advanced gastric cancer
Conditions
Interventions
S-1 monotherapy
oral S-1 80 mg/m2/day on days 1-14, q3 weeks.
S-1/DOC therapy
intravenous docetaxel 40 mg/m2 on day 1,
oral S-1 80 mg/m2/day on days 1-14, q3 weeks.
S-1+ip PTX therapy
intraperitonea
Sponsors
Ishigami Hironori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmation before temporary registration 1)Pathologically diagnosed as gastric adenocarcinoma of the general type. 2)The naked eye type is type 4 (diffuse infiltration type) or macroscopic type is type 3 (ulcerative-infiltrative type), with a maximum diameter of 8 cm or greater, and the histological type is undifferentiated. 3)Suspected invasion of the primary lesion to the subserosal layer(cT3-4) by diagnostic imaging 4)No Bulky N lymph node metastasis on CT. 5)No clear distant metastasis on image diagnosis. 6)Age >=20, =1,500/mm3 2.Hemoglobin >=8.0g/dL 3.Platelet >=100,000/mm3 4.AST =50mL/min 10)Possible to oral intake. 11)Written informed consent. Confirmation before main registration 12)Examination Laparoscopy does not show gross peritoneal dissemination 13)Regarding the residual tumor after peritoneal lavage cytology and surgery, one of the following applies. 1.Peritoneal lavage cytology was negative (CY0) and gross curative resection (R0-1) was performed. 2.Peritoneal lavage cytology is positive (CY1) and macroscopic curative resection (R0-1) is considered possible.
Exclusion criteria
Exclusion criteria: 1)Simultaneously active double cancer. 2)Severe complication (interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, uncontrolled hypertension, heart failure, renal failure, cirrhosis, liver failure, etc.) 3)Contraindication to tegafur, gimeracil, oteracil potassium(S-1), docetaxel hydrate(docetaxel), paclitaxel or oxaliplatin. 4)Pregnancy, breast feeding or intention to become pregnant. 5)Judged inappropriate for this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Peritoneal dissemination survival, Adverse event occurrence status, Preoperative chemotherapy completion rate, Curative resection rate, Histologic response rate | — |
Contacts
Public ContactHironori Ishigami
The University of Tokyo Hospital
Outcome results
None listed