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

NCT ID: NCT00964457

Last Updated: 2009-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2017-07-31

Brief Summary

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response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Detailed Description

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Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Conditions

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Rectum Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capecitabine, oxaliplatin

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

cetuximab 500mg per meter square every second week

capecitabine, oxaliplatin and cetuximab

capecitabine, oxaliplatin ane cetuximab

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

cetuximab 500mg per meter square every second week

Interventions

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cetuximab

cetuximab 500mg per meter square every second week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* advanced rectum cancer

Exclusion Criteria

* prior radiation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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hospital

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GI0905

Identifier Type: -

Identifier Source: org_study_id

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