gastric caner
Conditions
Interventions
Trial group (NIPS group): PO S-1+ IV?IP PTX:S-1 orally twice daily by a dose of 80 mg/m/day for 14 consective days, followed by 7 days rest. PTX i.v. by a dose of 50 mg/ and i.p. by 20 mg/ on days 1 a
Control group (PS group): PO S-1+IV PTV:S-1 orally twice daily by a dose 40-60 mg/m2/day for 14 consective days, followed by 7 days rest. PTX i.v. by a dose 70 mg/m2 on days 1 and 8. The treatment cou
Sponsors
Rui Jin Hospital, Shanghai Jiaotong University Shool of Medicine, Shanghai Institute of Digestive Surgery, Shanghai Key Laboratory of Stomach Neoplasma
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Gastric adenocarcinoma confirmed by histology or cytology, and have no operation history of primary lesion or metastatic lesion; 2. Metastasis of peritoneum should be confirmed by laparoscopy, without gastric outlet obstruction and intestinal obstruction; 3. Untreated (e.g. radiotherapy and chemotherapy ect); 4. Aged 18-75 years old; 5. ECOG (Eastern Cooperative Oncology Group) 0-2; 6. Expected lifetime >3 months; 7. Laboratory examination indicates tolerable to operation and chemotherapy; 8. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Signs of distal metastasis other than the peritoneum; 2. Pregnant or lactating women; 3. History of other malignancies within 5 years; 4. The severity of patients with uncontrolled epilepsy, central nervous system disease or psychogeny should be judged by the researchers, which may hinder the compliance of signing informed consent or drugs intaking; 5. Patients with heart disease with apparent clinical symptoms, coronary heart disease with symptoms, grade II or more severe congestive heart failure, drug controllable arrhythmia, and myocardial infarction within 12 months; 6. Patients associated with upper gastrointestinal tract obstruction or dysfounction, or with malabsorption syndrome, which may affect S-1 absorptioin; 7. The existence of the peripheral nervous system disorders=NCI-CTC AE I,but with only the disapperance of deep tendon reflex should not be excluded; 8. The history of organ transplants and the needs of immunosuppression therapy; 9. Uncontrolled severe inflammation or suffered other severe diseases; 10. Moderate or severe renal impairment (CCR=50ml/min), or serum creatinine greater than normal line; 11. Patients lack of dihydropyrimidine dehydrogenase; 12. Allergy to PTX or other drugs in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
China
Contacts
Public ContactZhenggang Zhu
Department of Gastrointestinal Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Digestive Surgery
Outcome results
None listed