A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
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|ClinicalTrials.gov Identifier: NCT00190515|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: 5FU+l-leucovorin Drug: UFT+Leucovorin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: 1
- Disease-free survival [ Time Frame: during the study conduct ]
- Overall survival [ Time Frame: during the study conduct ]
- Rate of adverse event [ Time Frame: during the study conduct ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190515
|Study Chair:||Yoshihiro Moriya, MD||National Cancer Center Hospital|