Docetaxel and S-1 as adjuvant chemotherapy for pathological stage II, IIIA, IIIB gastric cancer

UMIN ID: UMIN000000857

Registered date:19/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pathological stage II, IIIa, or IIIb gastric cancer
• Date of first enrollment: 2007/06/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel(40mg/m2, day1), S-1(80mg/m2, day1-14) combination therapy, every 3 weeks, 4 cycles followed by S-1(80mg/m2, day1-14) monotherapy every 3 weeks until 1 year from surgery.

Outcome(s)

• Primary Outcome: Feasibility of Docetaxel+S-1 4 cycles
• Secondary Outcome: Feasibility of Docetaxel+S-1 4 cycles followed by S-1 alone for 1 year, Safety

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix. 2. Contraindication to S-1 3. Under treatment with flucytosine, phenytoin, or warfarin 4. Past history of severe drug hypersensitivity. 5. Uncontrolled medical conditions (e.g., Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray, malignant hypertension, congestive heart failure, myocardial infarction in previous 6 months, arrhythmia requiring treatment, hemorrhage, diabetes). 6. Hepatitis B/C 7. Diarrhea 8. Pregnant or lactating women and women of child bearing potential not using contraception 9. Severe peripheral edema. 10. Grade 2 or greater peripheral neuropathy. 11. HIV positive. 12. Patients judged by the investigator as unfit to be enrolled in the study.

Related Information

• Primary Sponsor: Dept. of Surgery and Science, Kyushu University
• Source(s) of Monetary Support: none