An investigational study of chemoradiosensitivity prediction with genetic profiling of esophageal biopsy for squamous cell carcinoma of the esophagus

UMIN ID: UMIN000000479

Registered date:01/02/2007

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 2007/02/01
• Target sample size: 160
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): CDDP 70mg/m2 day1, day 29,5-FU 700mg/m2 day 1-4, day 29-32+radiation 60Gy or CDDP 75mg/m2 day1, day 29, 5-FU 1000mg/m2 day 1-4, day 29-32+radiation 50.4Gy. Salvage surgery for nonCR case

Outcome(s)

• Primary Outcome: 1 year disease free survival
• Secondary Outcome: 1 year local disease free survival, 3 year disease free survival, 3 year over all survival, pathological complete response

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Severe complication (heart failure, renal failure, hepatic failure, uncontrollable diabetes melitus) 2) Active bacterial infection 3) Previous radiotherapy for the chest 4)Interstitial Pneumonitis or pulmonary fibrosis 5) Tumor extend to the cervical esophagus or cardia of the stomach 6) Synchronous or metachronous malignancy 7) Multiple and different histological types of cancer 8) Pregnant female 9) Mental disease 10) Collagen disease (PSS, dermatomiositis ) 11) Tumor diameter, 8cm >= 12) Virus infection (HBV, HCV, PTHA, HIV)

Related Information

• Primary Sponsor: University of Toyama
• Secondary Sponsor: Translational Research Informatics Center, Foundation for Biomedical Research and Innovation
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): TRIEC0601