locally advanced rectal cancer
Conditions
Sponsors
Niigata Colorectal cancer Chemotherapy Study Group (NCCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Main lesion of the tumor is located at the Ra or Rb 2) Histologically confirmed Rectum adenocarcinoma 3) Clinical stage T3, any N, or T4, any N 4) Possigle to R0 resection 5) without metastases 6) without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 7) with measurable lesion 8) without ileus 9) age of 20-80 years 10) Eastern Cooperative Oncology Group performance status (PS) 0-1 11) survival period more than 3 months 12) adequate function of important prgans 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <100IU/L 6. bBil: <=2.0mg/dL 7. cCreatinin: <=1.0mg.DL or creatinin clearance level >= 60mi/min 13) written informed concent 14) with ability of oral intake
Exclusion criteria
Exclusion criteria: 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) were systemically-administered of steroids 15) with jaundice 16) except referred to above, physician in charge of this trial gave a diagnosis the patient who can not joint this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival, Overall survival, Resection rate, Safety, Curative resection rate, histological response evaluation, rate of sphincter-preservation | — |
Countries
Japan
Contacts
Public ContactYasumasa Takii
Niigata Cancer Center Hospital Surgery
Outcome results
None listed