UMIN ID: UMIN000001704
Registered date:17/02/2009
A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer
Basic Information
Recruitment status | Complete: follow-up continuing |
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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 |
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Secondary Outcome | pathological complete response rate pathological response rate adverse event overall survival |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 75years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Taiho pharmaceutical CO., LTD. |
Secondary ID(s) |
Contact
public contact | |
Name | |
Address | Japan |
Telephone | |
Affiliation | Tokushima university Department of surgery and transplantation |
scientific contact | |
Name | Mitsuo Shimada |
Address | 3-18-15 Kuramoto, Tokushima Japan |
Telephone | |
Affiliation | Tokushima university Department of surgery and transplantation |