A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer

UMIN ID: UMIN000001704

Registered date:17/02/2009

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: rectal cancer,lower tumor margin is below the peritoneal reflection
• Date of first enrollment: 2008/04/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

UFT 300mg/m2/day 1-5,8-12,15-19,22-26 Radiotherapy 2gy 5days a week for 4weeks
-1 80mg/m2/day 1-5,8-12,15-19,22-26 Radiotherapy 2gy 5days a week for 4weeks

Outcome(s)

• Primary Outcome: response rate
• Secondary Outcome: pathological complete response rate pathological response rate adverse event overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1,apparent or previous history of interstitinal pneumonitis or pulmonary fibrosis 2,pleural effusion or ascites requiring treatment 3,multiple malignancies 4,infection,paralysis of intestine or ireus 5,diarrhea(watery stool) 6,uncontrollacle diabetes 7,severe complication(heart failure,renal failure,hepatic insufficiency) 8,brain metastasis or treated brain metastasis 9,preqnant or lacting,capable of preqnancy or intend to get preqnant 10,previus serius medical illness or allergy for drug 11,critical mental disturbance 12,systemically administrered of steroids 13,judged in appropriate for this study by the physycians

Related Information

• Primary Sponsor: Tokushima university
• Source(s) of Monetary Support: Taiho pharmaceutical CO., LTD.