unresectable or recurrent gastric cancer
Conditions
Interventions
TS-1 : 80mg/m2/day po on Days 1-14 Cisplatin : 60mg/m2 iv on Day 1 Lentinan : 2mg/body iv on Day 1 , 8, 15
Sponsors
Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed gastric adenocarcinoma. 2. Measurable or evaluable lesion is confirmed within 28 days before enrollment. Presence of measurable and evaluable lesion is not required. 3. No prior chemotherapy or radiotherapy for gastric cancer. 4. Adequate baseline organ and marrow function within 14 days before enrollment as defined below; a. Hemoglobin : >= 8.0g/dL b. Leukocytes : 3,500-12,000/mm3 c. Absolute neutrophil count : >= 2,000/mm3 d. Platelets : >= 100,000/mm3 e. Total bilirubin : <= 1.5mg/dL f. AST (SGOT)/ALT (SGPT) : < 100IU/L g. ALP : <= twice institution baseline h. Creatinine clearance : >= 60mL/min 5. Performance status (ECOG scale) 0 &#8211; 2 6. Expected survival : >= 3 months 7. Age 20-75 8. Patients able to take orally 9. Patients should sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are contraindicated to S-1, CDDP, and Lentinan. 2. Patients with active infection. 3. Patient with a previous history of congestive heart failure. 4. Serious complication as followings ; a. Short bowel obstruction b. Interstitial pneumonia, Pulmonary fibrosis c. Uncontrolled diabetes mellitus d. Renal failure e. Hepatic failure 5. Patients with massive ascites or pleural effusion. 6. Patient with bone metastasis. 7. Patient with brain metastases or previous history of brain metastasis. 8. Patients with fresh bleeding from gastric cancer and/or the digestive tract. 9. Patients with diarrhea (4 or more times per day or watery diarrhea). 10. Patients who take psychotropic drug. 11. Patients with second primary malignancy. 12. Women in pregnancy, at risk of pregnancy, hoping to become pregnant. 13. Men who want their partners to become pregnant. 14. Any patients judged by the investigator to be unfit to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Treatment Failure (TTF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate (RR) Overall survival (OS) Progression Free Survival (PFS) Safety | — |
Countries
Japan
Contacts
Public ContactHirokazu Kiyozaki
Jichi Medical University, Saitama Medical Center Department of Surgery
Outcome results
None listed