This is a randomized controlled study designed to evaluate the relapse-free survival of the UFT group compared with the CMF group. Patients will be randomly assigned to receive either CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on recurrence, and survival will be collected for up to 10 years after enrollment of the final patient. To assess safety, data on adverse events will be collected for 2 years after the start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,300
uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years
cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
National Cancer Center
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Relapse-free survival
Time frame: every course for first three courses, then every other course
Overall survival, adverse events, and the quality of life
Time frame: any time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.