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A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)

2014-08-27 03:50:06 | BioPortfolio

Summary

To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy for stage III colorectal cancer.

Description

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 Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Colorectal Neoplasms

Intervention

5FU+l-leucovorin, UFT+Leucovorin

Location

Aichi Cancer Center Hospital
1-1,Kanokoden,Chikusa-ku,Nagoya
Aichi
Japan
464-8681

Status

Active, not recruiting

Source

Japan Clinical Oncology Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:50:06-0400

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Medical and Biotech [MESH] Definitions

The active metabolite of FOLIC ACID. Leucovorin is used principally as its calcium salt as an antidote to folic acid antagonists which block the conversion of folic acid to folinic acid.

A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.

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Hereditary nonpolyposis colorectal neoplasms associated with other malignancies, more commonly of ovarian or uterine origin. When also associated with SEBACEOUS GLAND NEOPLASMS, it is called MUIR-TORRE SYNDROME.

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