Status:
COMPLETED
Response Prediction in Metastasized Colorectal Cancer Using Intratumoral Thymidylate Synthase
Lead Sponsor:
University of Ulm
Collaborating Sponsors:
Pfizer, Berlin Germany
Medac, Hamburg, Germany
Conditions:
Colorectal Cancer
Non Resectable Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The aim of the study was to evaluate the feasibility of TS determination in a multicenter trial setting using a central facility for measurement and confirm its role as predictive factor for 5-FU trea...
Detailed Description
Eligible were patients with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy.The biopsy...
Eligibility Criteria
Inclusion
- patients (\>= 18 years) with non-resectable metastasized or recurrent histologically proven CRC with the presence of a reference lesion two-dimensional measurable and accessible for a biopsy
- a performance status WHO 0-2 (Karnofsky \>= 60%)
- an estimated life expectancy of at least 3 months
- written informed consent
Exclusion
- patients older than 75 years not fulfilling these criteria
- brain metastases or a secondary cane
- a history of a systemic palliative chemotherapy
- and an adjuvant chemotherapy (within 6 months)
- pregnant or nursing women
- a known allergy toward irinotecanhydroclorid or of any ingredients of Campto or other severe medical
- laboratory and social conditions not allowing chemotherapy and follow-up
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01212718
Start Date
July 1 2001
End Date
September 1 2010
Last Update
October 1 2010
Active Locations (1)
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1
Department of General, Visceral, and Transplantations Surgery, Univeristy of Ulm
Ulm, Germany