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A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer

A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer - A Randomized phaseII trial of chemoradiotherapy with UFT versus S-1 for low rectal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001704
Enrollment
60
Registered
2009-02-17
Start date
2008-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer,lower tumor margin is below the peritoneal reflection

Interventions

UFT 300mg/m2/day 1-5,8-12,15-19,22-26 Radiotherapy 2gy 5days a week for 4weeks -1 80mg/m2/day 1-5,8-12,15-19,22-26 Radiotherapy 2gy 5days a week for 4weeks

Sponsors

Tokushima university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1,histologically confirmed rectal cancer 2,clinical stage T1-T4 for EUS or CT 3,lower tumor margin is below the peritonal reflection 4,weasurable resion 5,no evidence of peritoneal metastasis 6,age 20-74 years old 7,performance status(ECPG) 0-2 8,possible to 3month survival 9,adequate organ function 10,no prior oparation,chemotherapy,radiotherapy 11,written informed concent 12,the case can eat

Exclusion criteria

Exclusion criteria: 1,apparent or previous history of interstitinal pneumonitis or pulmonary fibrosis 2,pleural effusion or ascites requiring treatment 3,multiple malignancies 4,infection,paralysis of intestine or ireus 5,diarrhea(watery stool) 6,uncontrollacle diabetes 7,severe complication(heart failure,renal failure,hepatic insufficiency) 8,brain metastasis or treated brain metastasis 9,preqnant or lacting,capable of preqnancy or intend to get preqnant 10,previus serius medical illness or allergy for drug 11,critical mental disturbance 12,systemically administrered of steroids 13,judged in appropriate for this study by the physycians

Design outcomes

Primary

MeasureTime frame
response rate

Secondary

MeasureTime frame
pathological complete response rate pathological response rate adverse event overall survival

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026