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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00278694
Other study ID # S-05059
Secondary ID Eudractnr 2005-0
Status Completed
Phase Phase 2
First received January 16, 2006
Last updated September 28, 2016
Start date September 2005
Est. completion date February 2016

Study information

Verified date September 2016
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial Summary

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.


Description:

Effect of treatment, safety profile and quality of life scorings.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Rectal cancer

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oxaliplatin

Chemoradiation

5-FU

Radiation:
Preoperative chemoradiation

Procedure:
Pelvic surgery

Drug:
Neoadjuvant oxaliplatin


Locations

Country Name City State
Norway RRHF Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety profile 5 years Yes
Primary Number of patients obtaining pCR 5 years Yes
Secondary Clinical, radiological and molecular response to treatment 5 years Yes
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