Phase II study of preoperative chemotherapy using FOLFOX for obstructive colon cancer
- Conditions
- obstructive colon cancer
- Registration Number
- JPRN-UMIN000013198
- Lead Sponsor
- Yokohama City University Medical Center
- Brief Summary
The objective response rate as the primary endpoint was 67.4%. Neoadjuvant chemotherapy using mFOLFOX6 was feasible and might be a treatment option for patients with obstructive colon cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method adverse event rate, surgical complication rate, R0 resection rate, CR rate, completion rate, relapse free survivalrate, overall survival rate