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:
Copenhagen University Hospital at Herlev
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 (Adult, Senior) |
| 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
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 |
| 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 Capecitabine Oxaliplatin Cetuximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 27, 2016