Phase II trial of neoadjuvant chemotherapy for unresectable liver metastasis of colorectal cancer
- Conditions
- Colorectal cancer patients with unresectable liver metastasis
- Registration Number
- JPRN-UMIN000006994
- Lead Sponsor
- Surgery, Kyorin university hospital
- Brief Summary
This clinical trial was discontinued due to a lack of case accumulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1) Patients with previous histories of severe drug hypersensitivity or drug allergies 2) Patients with multiple primaries 3) Patients with metastasis outside the liver and regional lymph nodes 4) Patients with infection (fever of 38 degrees C or over) 5) Patients with severe comobidities (interstitial pneumonia or pulmonary fibrosis, cardiac failure, renal failure, liver failure, uncontrollable diabetes or hypertension, jaundice) 6) Patients with pleural effusion or ascites requiring treatment 7) Patients with diarrhea (watery) 8) Patients receiving atazanavir sulfate or flucytosine treatment 9) Pregnant women and women suspected of being pregnant and lactating women 10) Patients evaluated as unsuitable for this trial by the doctor in charge 11) Patients with arterial or venous thrombosis in KRAS mutant cases
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method R0 resection rate in FOLFIRI+Cetuximab treatment
- Secondary Outcome Measures
Name Time Method R0 resection rate in FOLFOX+Bevacizumab treatment, response rate and efficacy in both treatments