Preoperative chemoradiotherapy for advanced rectal cancer
- Conditions
- Rectal or anal cancer
- Registration Number
- JPRN-jRCTs031180291
- Lead Sponsor
- eno Hideki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
(1) Rectal or anal cancer whose lower tumor margin is below the peritoneal reflection. The clinical stage is II or III.
(2) Histologically confirmed adenocarcinoma
(3) Without prior anti-tumor therapy
(4) Age:20-80years old
(5) Performance status 0-2
(6) Adequate organ function
WBC>= 4,000 <= 15,000/mm3
neutro>= 2,000/mm3
Plt>= 100,000/mm3
Hb>= 8.0g/dl
Cr<= 1.5mg/dl
T-Bil<= 1.5mg/dl
AST, ALT<= double of the upper limit
(7) Written IC with date
(1) Severe diabetes
(2) Severe hypertension
(3) Interstitial pneumonitis, pulmonary fibrosis, severe pulmonary emphysema
(4) Active chronic hepatitis B or C
(5) Blood Transfusion within the last 2 weeks
(6) Patients with mental diseases judged inappropriate for this study by the physicians
(7) Without written IC with date
(8) Contraindication for taking CPT-11
(9) Contraindication for taking S-1
(10) Patients judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete Response Rate
- Secondary Outcome Measures
Name Time Method 1) Local recurrence free survival<br>2) Relapse free survival (RFS) <br>3) Overall survival (OS)