Feasibility trial of neoadjuvant chemotherapy with docetaxel,cisplatin and fluorouracil for clinical stage II/III esophageal carcinoma.

UMIN ID: UMIN000002396

Registered date:01/09/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: esophageal neoplasm
• Date of first enrollment: 2009/07/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

initial cohort n=30 aged 70 or younger docetaxel 70 mg/m2/day day1 iv cisplatin 70 mg/m2/day day1 iv 5-fluorouracil 750 mg/m2/day day1-5 civ q3w , 3 cycle Esophagectomy with D2 (or more) lymph node desection
expanding cohort n=10 aged 75 or younger docetaxel 75 mg/m2/day day1 iv cisplatin 75 mg/m2/day day1 iv 5-fluorouracil 750 mg/m2/day day1-5 civ q3w , 3 cycle Esophagectomy with D2 (or more) lymph node desection

Outcome(s)

• Primary Outcome: The rate of treatment completion
• Secondary Outcome: Overall survival Progression free survival Resectability rate Adverse event Response rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Simultaneous or metachronous (within 5 years) double cancers , with the exception of intramucosal tumor curable with local therapy 2) Pregnant or lactating women or women of childbearing potential 3) Psychosis 4) Patients requiring systemic steroids medication 5) HBs antigen positive 6) Uncontrollable diabetes millutus 7) History of myocardial infarction or unstable angina pectoris or interstitial pneumonia or fibroid lung or severe emphysema 8) Active bacterial or fungous infection

Related Information

• Primary Sponsor: Saitama Cancer Center
• Source(s) of Monetary Support: Foundation for promotion of cancer research in Japan