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Phase2 study of limited Surgery for T1 or T2 lower rectal Cancer with adjuvant chemoradiotherapy

Phase 2
Conditions
Rectal cancer
Registration Number
JPRN-UMIN000007184
Lead Sponsor
Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1)Active synchronous or metachronous malignancy carcinoma in situ. 2) Non-treated radiotherapy 3) Medical history of severe anaphylaxis or allergia to any drug. 4) Severe diarrhea. 5)Undergoing treatment with fluorocytosine. 6) Severe complication. 7) Pregnant or lactating woman at any time during study. Men of the fertility hope. 8) Severe mental disorder. 9) Patients judged inappropriate for the study by their physicians.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relapse-free survival
Secondary Outcome Measures
NameTimeMethod
Disease-free survival Overall survival Local relapse-free survival Adverse events, Anal sphincter preservation Anal function
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