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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectum Cancer | Drug: cetuximab | Phase 2 |
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 |
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
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Drug: cetuximab
cetuximab 500mg per meter square every second week
|
- response rate [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- advanced rectum cancer
Exclusion Criteria:
- prior radiation

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
Denmark | |
Herlev Hospital | Active, not recruiting |
Herlev, Denmark, 2730 |
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 |