Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients
Treatment of Patient With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before Under and After Radiation and With Adding Cetuximab to K_RAS Wild-type Patients.
1 other identifier
interventional
60
1 country
1
Brief Summary
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2009
Longer than P75 for phase_2
1 active site
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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 25, 2009
August 1, 2009
2.9 years
August 21, 2009
August 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate
3 years
Study Arms (2)
Capecitabine, oxaliplatin
ACTIVE COMPARATORcapecitabine, oxaliplatin and cetuximab
ACTIVE COMPARATORcapecitabine, oxaliplatin ane cetuximab
Interventions
cetuximab 500mg per meter square every second week
Eligibility Criteria
You may qualify if:
- advanced rectum cancer
You may not qualify if:
- prior radiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herlev Hospital
Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 21, 2009
First Posted
August 25, 2009
Study Start
August 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2017
Last Updated
August 25, 2009
Record last verified: 2009-08