Phase II study of neoadjuvant chemotherapy with L-OHP and S-1 for locally advanced colorectal cancer with lymph node metastases
- Conditions
- locally advanced colorectal cancer with lymph node metastases
- Registration Number
- JPRN-UMIN000003529
- Lead Sponsor
- iigata Colorectal cancer Chemotherapy Study Group (NCCSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1)with sensory neuropathy 2)with active double cancer 3)had active infection disease (over 38.0 degree) 4)with sever diarrhea 5)had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 6)with previous serious drug hyperseneitivity 7)with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 8)with myelosupression 9)with chickenpox 10)had pleural effusion or ascites which need therapy 11)receiving Flucytosine 12)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 13)had a previous serious drug allergies 14).clinical evidence of CNS metastases or had a history of brain metastasis 15)were systemically-administered of steroids 16)with jaundice 17)except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Relapse free survival of 3 years, Overall survival, Resection rate, Safty, Curative resection rate, histological response evaluation