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

History of Changes

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: 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:

Drug Information available for: Oxaliplatin Capecitabine Cetuximab

U.S. FDA Resources

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


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

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


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

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 Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017

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