Status:
TERMINATED
Tailored Treatment in Metastatic Colorectal Cancer
Lead Sponsor:
Vejle Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
To compare the response rate of single agent chemotherapy in advanced colorectal cancer given as standard treatment versus tailored treatment in a randomised phase III trial.
Detailed Description
The TS and MTHFR polymorphism has been investigated in a new study based on analysis of normal tissue. The results indicated that protein with a 3/3 TS polymorphism or a MTHFR T polymorphism had a sig...
Eligibility Criteria
Inclusion
- Metastatic colorectal cancer
- Histopathological verification of the primary tumor
- Measurable disease according to RESIST criteria
- Single agent chemotherapy indicated
- Performance status \>=2
- Age \>= 60 years
- Life expectancy \> 3 months
- Adequate liver and kidney function as evaluated by bilirubin \<= 3 times of normal upper limit, ALAT \<= 3 times upper normal limit (\<= 5 times upper normal limit in case of liver metastases), serum creatinine \<= 1.5 times normal upper limit.
- ANC \>=1.5 x 109/l and platelets \>= 100 x 109/l
- Informed consent
Exclusion
- Patients with CNS metastases
- Other malignant disease within the last 5 years except for non-melanoma skin cancer and carcinoma in situ of cervix uteri
- Previous chemotherapy for metastatic disease
- Adjuvant chemotherapy \< 6 months before inclusion
- Patients with previous major toxic or allergic reaction to the protocol drugs
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00396487
Start Date
November 1 2006
End Date
February 1 2008
Last Update
June 11 2015
Active Locations (10)
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1
Aalborg Hospital
Aalborg, Denmark, 9100
2
Aarhus University Hospital
Aarhus, Denmark, 8000
3
Rigshospitalet
Copenhagen, Denmark, 2100
4
Sydvestjysk Hospital Esbjerg
Esbjerg, Denmark, 6700