imited Surgery for T1 or T2 lower rectal Cancer with neoadjuvant chemoradiotherapy
Phase 2
Recruiting
- Conditions
- Rectal cancer
- Registration Number
- JPRN-UMIN000037000
- Lead Sponsor
- Osaka Rosai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
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 Tegafur, Gimeracil, Oteracil Potassium. 6) Undergoing treatment with Warfarin Potassium, Phenytoin, Trifluridine, Tipiracil Hydrochloride. 7) Severe complication. 8) Pregnant or lactating woman at any time during study. Men of the fertility hope. 9) Severe mental disorder. 10) Patients judged inappropriate for the study by their physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response rate
- Secondary Outcome Measures
Name Time Method Relapse-free survival Disease-free survival Overall survival Local relapse-free survival Adverse events Anal sphincter preservation Anal function