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Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers

Phase 2
18 Years
75 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers

More and more colorectal surgeons believe that surgical resections of hepatic metastases
from colorectal cancer is the only chance for cure of patients. The five-year survival for
patients with hepatic metastasis from colorectal cancer after surgical resection is
approximately 30 %. However, most hepatic metastases from colorectal cancer were inoperable.
With the progress of chemotherapy, for example, the combination of the 5-Fu, leucovorin, and
oxaliplatin, some surgeons advocated that approximately 20% of inoperable liver metastases
will be converted to operable case, thus providing the long-term survival for patients. In
this study, we made a phase Ⅱ clinical trial regarding the use of the Folfox-4 regimens in
the neo-adjuvant treatment of inoperable hepatic metastases. Our aims is to evaluate the
tumor response rate for this regimen, the rate of resectability of liver metastases,
progression free survival and overall survival of patients. In addition, the difference
between the reports from Western and Oriental countries will be analyzed. We believe this
study will provide new perspectives regarding the most beneficial treatment modalities for
the patients with hepatic metastases from colorectal cancer.

Inclusion Criteria:

- 1. colorectal cancer with primarily non-resectable hepatic metastasis, defined as
(one of the following): (1) liver metastases > five; (2) liver metastases are
anatomically or functionally non-resectable (e.g. insufficient functional liver
tissue, liver venous infiltration, liver arterial infiltration, …..) 2. No
extra-hepatic disease 3. No prior chemotherapy, except adjuvant chemotherapy 4.
Primary tumor resection >1 month 5. Signed written informed consent 6. Male or female
18 - 75 years of age 7. Histologically confirmed adenocarcinoma of the colon or
rectum 8. No extra-hepatic disease 9. Presence of at least one bi-dimensional
indicator lesion measurable by CT scan or MRI not in an irradiated area 10. Life
expectancy of >= 3 months 11. Karnofsky performance status >= 70% 12. Neutrophils >=
1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL 13. Bilirubin level <
1.5 x ULN 14. ASAT and ALAT £ 2.5 x ULN (<= 5 x ULN if liver metastasis are present)
15 Serum creatinine < 1.5 x ULN 16. Effective contraception for both male and female
patients if the risk of conception exists

Exclusion Criteria:

- 1. Brain metastasis (known or suspected) 2. Concurrent chronic systemic immune
therapy, chemotherapy, or hormone therapy not indicated in the study protocol 3. Any
investigational agent(s) within 4 weeks prior to entry 4. Previous exposure to
monoclonal antibodies, signal transduction inhibitors or other EGFR-targeting therapy
5. Clinically relevant coronary artery disease or a history of a myocardial
infarction within the last 12 months 6. Acute or subacute intestinal occlusion or
history of inflammatory bowel disease Known grade 3 or 4 allergic reaction to any of
the components of the treatment 7. Known drug abuse/ alcohol abuse 8. Legal
incapacity or limited legal capacity 9. Medical or psychological condition which in
the opinion of the investigator would not permit the patient to complete the study or
sign meaningful informed consent 10. Women who are pregnant or breastfeeding 11.
Clinically relevant peripheral neuropathy 12. Any concurrent malignancy other than
non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a
previous malignancy but without evidence of disease for >= 5 years will be allowed to
enter the trial)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Response rate and resectability after neoadjuvant therapy.

Principal Investigator

Jin-Tung Liang, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.


Taiwan: Department of Health

Study ID:




Start Date:

January 2000

Completion Date:

June 2005

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • Chemotherapy
  • Surgery
  • Liver metastasis
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms