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Phase 2
20 Years
80 Years
Open (Enrolling)
Both
Colorectal Cancer, Liver Metastasis

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Trial Information


Inclusion Criteria:



1. Histologically diagnosed as colorectal adenocarcinomas, including cecal, appendiceal,
and anal canal cancers.

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:

Excluded are cases with conditions as below:

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Curative resection rates of liver metastases

Outcome Time Frame:

2 years after the operations

Safety Issue:

Yes

Authority:

Japan: Institutional Review Board

Study ID:

C-206

NCT ID:

NCT00594529

Start Date:

January 2008

Completion Date:

May 2013

Related Keywords:

  • Colorectal Cancer
  • Liver Metastasis
  • Neoadjuvant chemotherapy
  • Metastatic liver lesions from colorectal cancers
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

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