Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Rectal Cancer Clinical Trial

— LARC-RRP  

Official title:

Oxaliplatin and 5-FU Based Preoperative Chemoradiation

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

• Rectal Cancer
• Rectal Neoplasms

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