Phase II study of S-1 and L-OHP neoadjuvant chemotherapy with total mesorectal excision and lateral lymph node dissection for resectable rectal cancer (ACCS-01)
- Conditions
- locally advanced rectal cancer
- Registration Number
- JPRN-UMIN000019606
- Lead Sponsor
- Gastroenterological surgery, Hirosaki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 65
Not provided
1) with gastrointestinal ulceration or bleeding 2) with sensory neuropathy 3) with severe diarrhea 4) had a previous serious drug allergies 5) had pleural effusion or ascites which need therapy 6) with brain metastasis or suspected the brain metastases 7) had surgery within 28 days before registration 8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 10) with active double cancer 11) had active infection disease (over 38.0 degree) 12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 13) receiving Flucytosine 14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 15) were systemically-administered of steroids 16) with contraindications to TS-1 and L-OHP 17) with HBsAg-positive 18) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method