Status:
UNKNOWN
Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 hepati...
Detailed Description
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 hepati...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00172159
Start Date
January 1 2000
End Date
June 1 2005
Last Update
June 23 2010
Active Locations (1)
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1
Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
Taipei, Taiwan, 100