A Phase II Study of TS-1 + CDDP + Lentinan combination chemotherapy for unresectable or recurrent gastric cancer

Not Applicable

Recruiting

• Conditions: unresectable or recurrent gastric cancer

• Registration Number: JPRN-UMIN000010724
• Lead Sponsor: Jichi Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to Treatment Failure (TTF)

Secondary Outcome Measures

Name	Time	Method
Response Rate (RR) Overall survival (OS) Progression Free Survival (PFS) Safety