Feasibility Study of Neoadjuvant Chemotherapy Modified FOLFOX6 for Resectable Liver Metastases of Colorectal Cancers
NCT ID: NCT00594529
Last Updated: 2011-06-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
27 participants
INTERVENTIONAL
2008-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Surgery
Liver resection for metastatic liver lesions
Interventions
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Surgery
Liver resection for metastatic liver lesions
Eligibility Criteria
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Inclusion Criteria
2. Liver lesions are measurable by spiral CT or SPIO-MRI scans.
3. Extrahepatic lesions include lung metastases which can be resected curatively.
4. Curative resection for metastatic lesions can be performed with residual hepatic functions preserved.
5. No prior treatment histories for liver lesions, including L-OHP regimens, hepatectomy, hepatic arterial infusion, MCT, or RFA
6. No evidence of chronic hepatic diseases which affect systemic chemotherapy and/or surgical resection
7. Performance status (ECOG): 0-1
8. Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved.
Exclusion Criteria
1. Peritoneal or pleural fluid retention to be drained.
2. Multiple malignancies to be treated.
3. Peripheral neural disturbances.
4. Active infectious diseases.
5. Severe watery diarrhea.
6. Mental disturbances.
7. Treatment history of continuous, oral or intravenous steroid therapy.
8. Previous history of ischemic heart diseases.
9. Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure.
10. Pregnant.
11. Previous history of severe drug-induced allergy.
20 Years
80 Years
ALL
No
Sponsors
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Kyoto University
OTHER
Responsible Party
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Dept. Surgery, Kyoto Univ.
Locations
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Kyoto University Hospital
Kyoto, , Japan
Countries
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Central Contacts
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Facility Contacts
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References
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Nagayama S, Hasegawa S, Hida K, Kawada K, Hatano E, Nakamura K, Seo S, Taura K, Yasuchika K, Matsuo T, Zaima M, Kanazawa A, Terajima H, Tada M, Adachi Y, Nishitai R, Manaka D, Yoshimura T, Doi K, Horimatsu T, Mitsuyoshi A, Yoshimura K, Niimi M, Matsumoto S, Sakai Y, Uemoto S. Multi-institutional phase II study on the feasibility of liver resection following preoperative mFOLFOX6 therapy for resectable liver metastases from colorectal cancers. Int J Clin Oncol. 2017 Apr;22(2):316-323. doi: 10.1007/s10147-016-1050-5. Epub 2016 Oct 17.
Other Identifiers
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UMIN000000961
Identifier Type: -
Identifier Source: secondary_id
C-206
Identifier Type: -
Identifier Source: org_study_id
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