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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964457
First Posted: August 25, 2009
Last Update Posted: August 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Copenhagen University Hospital at Herlev
  Purpose
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Condition Intervention Phase
Rectum Cancer Drug: cetuximab Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

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

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
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

Responsible Party: Ole Larsen, MD, Herlev hospital, hospital
ClinicalTrials.gov Identifier: NCT00964457     History of Changes
Other Study ID Numbers: GI0905
First Submitted: August 21, 2009
First Posted: August 25, 2009
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