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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

Primary Purpose

Rectum Cancer

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
cetuximab
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectum Cancer focused on measuring cetuximab, rectum cancer, radiation, MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • advanced rectum cancer

Exclusion Criteria:

  • prior radiation

Sites / Locations

  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Capecitabine, oxaliplatin

capecitabine, oxaliplatin and cetuximab

Arm Description

capecitabine, oxaliplatin ane cetuximab

Outcomes

Primary Outcome Measures

response rate

Secondary Outcome Measures

Full Information

First Posted
August 21, 2009
Last Updated
August 24, 2009
Sponsor
Copenhagen University Hospital at Herlev
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1. Study Identification

Unique Protocol Identification Number
NCT00964457
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Copenhagen University Hospital at Herlev

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer
Detailed Description
Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectum Cancer
Keywords
cetuximab, rectum cancer, radiation, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Capecitabine, oxaliplatin
Arm Type
Active Comparator
Arm Title
capecitabine, oxaliplatin and cetuximab
Arm Type
Active Comparator
Arm Description
capecitabine, oxaliplatin ane cetuximab
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
cetuximab 500mg per meter square every second week
Primary Outcome Measure Information:
Title
response rate
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: advanced rectum cancer Exclusion Criteria: prior radiation
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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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