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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

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ClinicalTrials.gov Identifier: NCT00964457
Recruitment Status : Unknown
Verified August 2009 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Not yet recruiting
First Posted : August 25, 2009
Last Update Posted : August 25, 2009
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Condition or disease Intervention/treatment Phase
Rectum Cancer Drug: cetuximab Phase 2

Detailed Description:
Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2017

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Capecitabine, oxaliplatin Drug: cetuximab
cetuximab 500mg per meter square every second week
Active Comparator: capecitabine, oxaliplatin and cetuximab
capecitabine, oxaliplatin ane cetuximab
 Drug: cetuximab
cetuximab 500mg per meter square every second week


Outcome Measures
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Primary Outcome Measures :
  1. response rate [ Time Frame: 3 years ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • advanced rectum cancer

Exclusion Criteria:

  • prior radiation
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964457


Locations
Denmark
Herlev Hospital Active, not recruiting
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Ole Larsen, MD, Herlev hospital, hospital
ClinicalTrials.gov Identifier: NCT00964457     History of Changes
Other Study ID Numbers: GI0905
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: August 25, 2009
Last Verified: August 2009

Keywords provided by Copenhagen University Hospital at Herlev:
cetuximab
rectum cancer
radiation
MRI

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents