obstructive colon cancer
Conditions
Interventions
1. diverting stoma patients undego making divering stoma for the purpose of the intestinal decomplession. 2. neoadjuvant chemotherapy (6 courses of FOLFOX) It stats within 4 weeks after making di
Sponsors
Yokohama City University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of obstructive colon adenocarcinoma 2. 1) clinical stage II, III 2) tumor location is from cecum to rectosigmoid. 3) Fillful at least one or more criteria of intestinal obstruction following, i) unable to eat ii) no flatus iii) existance of abdominal distension iV) neveau in abdominal X-ray 4) aged between 20 and 80 years old 5) ECOG Performance status of 0 or 1 6) more than three months of expected survival time 7)at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 8) no prior chemotherapy or radiotherapy 9) adequate bone marrow function with absolute neutrophil count >1,500/microl, platelet count >100,000/microl, adequate liver function with total bilirubin<=2 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <=5 x ULN, adequate renal function with serum creatinine <=2 x ULN 10) willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1)history of severe drug hypersensitivity 2)history of having severe paresis or dysesthesia 3)history of another malignancy within 5 years 4)Active infections 5)Severe concurrent disease such as poorly controlled hypertension,poorly controlled diabetes,interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 6)serum HBs antigen positive 7)Ascites or pleural effusion requiring treatment 8)fresh intestinal bleeding 9)intestinal perforation or penetration 10)Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 11)Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event rate, surgical complication rate, R0 resection rate, CR rate, completion rate, relapse free survivalrate, overall survival rate | — |
Countries
Japan
Contacts
Public ContactMitsuyoshi Ota/ Atsushi Ishibe
Yokohama City University Medical Center Gastroenerological Center
Outcome results
None listed