Phase II study of Docetaxel and CDDP and 5-FU for metastatic esophageal cancer

UMIN ID: UMIN000000821

Registered date:07/09/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients to be registered Esophageal cancer with distant metastasis (Stage IVb or stage IVa with N4)
• Date of first enrollment: 2004/07/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Course 1 Course 2 Day 1 2 3 4 5 29 30 31 32 33 TXT O O CDDP O O 5-FU --------- -------------- 5-FU 600mg/m2 is administered (civ) between day 1 and day 5 CDDP 70 mg/m2 is administered (iv) by 120 minutes on day 1. TXT 60 mg/m2 is administered (iv) by more than 60 minutes on day 1.

Outcome(s)

• Primary Outcome: Response Rate
• Secondary Outcome: feasibility, survival period, survival time before progression (Time To Progression: TTP)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: 1) severe disorders in The other organs(cardiac disorder, pulmonary fibrosis or interstitial pneumonia, Liver dysfunction) 2) brain metastasis with symptoms 3) edema which needs treatment 4) severe infectious disease 5) with high fever upper than 38 0C 6) with active double cancer 7) women under pregnancy and/or nursing or women who expects pregnancy 8) with a history of severe allergic reaction against medicines 9) uncontrolled cavity fluid in the chest, abdomen or heart 10) doctor's decision not to register to this regimen

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization