Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
18 Years
N/A
Both
Liver Metastasis
Trial Information
Intrahepatic and Systemic Chemotherapy Together With Antibody to Patients With Non-resectable Liver Metastases From Solid Tumors
Two regiment are used: N.B. The two regiments will be reported separately
1. Mitomycin + Gemcitabine intrahepatic together with Capecitabine. This treatment can be
offered patients with solid tumors where all standard treatments have been used. The
patients are not allowed to have extrahepatic disease. The purpose of the treatment are
to prolonged life.
2. FOLFOX where oxaliplatin is given intrahepatic each second time. The treatment are only
for patients with colorectal cancer where cure is possible but resection straight ahead
is not possible. The patients are allowed to have their colorectal cancer in situ for
operation latter on. If the patients are KRAS Wild-type, cetuximab are added.
Inclusion Criteria:
- liver metastasis
- solid tumor
Exclusion Criteria:
- poor performance
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
tumor response according to RECIST 1.1. Number of patients with CR, PR, SD and PR will be recorded.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Finn O Larsen, M.D. , Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Unaffliated
Authority:
Denmark: Ethics Committee
Study ID:
AA-1023
NCT ID:
NCT01511146
Start Date:
July 2011
Completion Date:
July 2016
Related Keywords:
- Liver Metastasis
- oxaliplatin
- mitomycin
- gemcitabine
- intrahepatic
- liver metastasis
- response in liver metastasis
- downsized to operation
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Liver Neoplasms
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