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Sponsors and Collaborators: |
Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare |
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Information provided by: | Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00190515 |
To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: 5FU+l-leucovorin Drug: UFT+Leucovorin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF) |
Estimated Enrollment: | 1100 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | November 2011 |
Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.
UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five times every 5 weeks.
5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three times every 8 weeks.
Primary endpoints are disease-free survival and secondary endpoints are overall survival and adverse event rate.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Yoshihiro Moriya, MD | National Cancer Center Hospital |
Study ID Numbers: | JCOG-0205-MF, C000000193 |
Study First Received: | September 12, 2005 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00190515 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
adjuvant chemotherapy Stage III colorectal cancer 5-FU+l-LV UFT+LV randomized controlled trial |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil Colonic Diseases Leucovorin |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Vitamin B Complex Neoplasms by Site Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Pharmacologic Actions |