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Feasibility study of the adjuvant chemoradiotherapy for the patients with high-risk rectal submucosal invasive cancer after the local resectio

Not Applicable
Conditions
rectal cancer
Registration Number
JPRN-UMIN000016785
Lead Sponsor
ational Cancer Center Hospital East
Brief Summary

One patient was ineligible. Twenty-three patients completed treatment, with a completion rate of 82% (80% confidence interval, 69-91%); the remaining five patients completed treatment with protocol deviation. The median relative dose intensity of capecitabine was 100% (range, 58-100%). Common adverse events included radiation dermatitis (54%), anal pain (39%) and anal mucositis (29%). No grade-3 or higher adverse events were reported.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
29
Inclusion Criteria

Not provided

Exclusion Criteria

1)Presence of synchronous or metachronous advanced colorectal cancer and malignant diseases in any other organs 2)Pregnant woman 3)Patients with psychosis 4)Use of the phenytoin and warfarin potassium 5)Use of steroids 6)Activity of hepatitis B or hepatitis C 7)Systemic infection 8)Others

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The rate of treatment completion
Secondary Outcome Measures
NameTimeMethod
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