Phase II study of docetaxel and S-1 as neoadjuvant chemotherapy + gastrectomy for cStage IIIa-IIIb(IV) resectable gastric cancer

UMIN ID: UMIN000000875

Registered date:05/11/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: clinical stage IIIa-IIIb(IV) gastric cancer
• Date of first enrollment: 2007/11/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Docetaxel 35 mg/m2 1-hour IV days 1,15 S-1 80 mg/m2 PO BID days 1-14, every 28 days for 2 cycles followed by gastrectomy with D2 lymph node dissection

Outcome(s)

• Primary Outcome: Pathological response
• Secondary Outcome: Response rate of neoadjuvant chemotherapy Treatment completion rate Complete resection rate 3 year relapse free survival 3 year overall survival Adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 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, patients contraindicated to S-1, A history of severe drug hypersensitivity, Uncontrolled medical conditions , Documented or suspected infection, Patients requiring treatment with corticosteroids except for pre-medication, Hepatitis B or C, patients with diarrhea, Pregnant or lactating women and women of child bearing potential not using contraception, Severe psychiatric disorders, Severe edema, Grade 2 or grater peripheral neuropathy, HIV positive, 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