UMIN ID: C000000013
Registered date:01/07/2005
A randomized controlled trial by a parallel group design in multi-institutions to evaluate the effectiveness of oral adjuvant chemotherapy using Leucovorin and Tegaful/Uracil to prevent recurrence after resection of liver metastasis from colorectal carcinoma.
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Cases with liver metastasis from colorectal carcinoma, which is removed curatively and surgically. |
Date of first enrollment | 2004/02/01 |
Target sample size | 180 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Oral administration of Leucovorin (75mg/day) and Tegaful/Uracil (300mg/body surface area m2/day) for 5 courses (5 weeks of administration followed by 1 week of no administration) after curative resection of liver metastasis from colorectal carcinoma. Only follow-up without any anti-cancer therapy after curative resection of liver metastasis from colorectal carcinoma. |
Outcome(s)
Primary Outcome | Disease-free survival |
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Secondary Outcome | Overall survival |
Key inclusion & exclusion criteria
Age minimum | 20years-old |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
Exclude criteria | The patients with other malignant disease, post-operative severe complications, and surgical margin positivity. |
Related Information
Primary Sponsor | Hepato-Biliary-Pancreatic Surgery Division, Tokyo University Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | The Ministry of Education, Science, Sports and Culture.,Japanese Foundation for Multidisciplinary Treatment of Cancer. |
Secondary ID(s) |
Contact
public contact | |
Name | Norihiro Kokudo |
Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan |
Telephone | 03-3815-5411(33320) |
KOKUDO-2SU@h.u-tokyo.ac.jp | |
Affiliation | Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division |
scientific contact | |
Name | Norihiro Kokudo |
Address | 7-3-1, Hongo, Bunkyo-ku, Tokyo Japan |
Telephone | 03-3815-5411(33320) |
KOKUDO-2SU@h.u-tokyo.ac.jp | |
Affiliation | Tokyo University Hospital Hepato-Biliary-Pancreatic Surgery Division |