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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2009 by Copenhagen University Hospital at Herlev
Sponsor:
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00964457
First received: August 21, 2009
Last updated: August 24, 2009
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • advanced rectum cancer

Exclusion Criteria:

  • prior radiation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964457

Locations
Denmark
Herlev Hospital Active, not recruiting
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Ole Larsen, MD, Herlev hospital, hospital
ClinicalTrials.gov Identifier: NCT00964457     History of Changes
Other Study ID Numbers: GI0905
Study First Received: August 21, 2009
Last Updated: August 24, 2009
Health Authority: Denmark: Danish Medicines Agency

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
Oxaliplatin
Capecitabine
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014