Study Stopped
Only one patient included as per Feb. 4, 2008.
Tailored Treatment in Metastatic Colorectal Cancer
Tailored Treatment of Metastatic Colorectal Cancer Based on Genetic Markers
1 other identifier
interventional
1
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 6, 2006
CompletedFirst Posted
Study publicly available on registry
November 7, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedJune 11, 2015
June 1, 2015
November 6, 2006
June 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The primary end point is
Response according to RECIST criteria.
Secondary Outcomes (4)
Secondary end points are
Progression free survival
Overall survival
Toxicity
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Patients with previous major toxic or allergic reaction to the protocol drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vejle Hospitallead
Study Sites (10)
Aalborg Hospital
Aalborg, 9100, Denmark
Aarhus University Hospital
Aarhus, 8000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Sydvestjysk Hospital Esbjerg
Esbjerg, 6700, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Herning Central Hospital
Herning, 7400, Denmark
Næstved Hospital
Næstved, 4700, Denmark
Odense University Hospital
Odense, 5000, Denmark
Roskilde Hospital
Roskilde, 4000, Denmark
Viborg Hospital
Viborg, 8800, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Jakobsen, Prof, MDSc
Department of Oncology, Vejle Hospital, 7100 Vejle, DK-Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2006
First Posted
November 7, 2006
Study Start
November 1, 2006
Study Completion
February 1, 2008
Last Updated
June 11, 2015
Record last verified: 2015-06