Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Phase 2

Completed

• Conditions: Rectal Cancer
• Interventions: Drug: Oxaliplatin; Drug: Chemoradiation; Drug: 5-FU; Radiation: Preoperative chemoradiation; Procedure: Pelvic surgery; Drug: Neoadjuvant oxaliplatin

• Registration Number: NCT00278694
• Lead Sponsor: Oslo University Hospital

Brief Summary

Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Detailed Description

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

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemoradiation	Neoadjuvant oxaliplatin	Neoadjuvant chemotherapy and chemoradiation
Chemoradiation	Chemoradiation	Neoadjuvant chemotherapy and chemoradiation
Chemoradiation	Preoperative chemoradiation	Neoadjuvant chemotherapy and chemoradiation
Chemoradiation	Pelvic surgery	Neoadjuvant chemotherapy and chemoradiation
Chemoradiation	Oxaliplatin	Neoadjuvant chemotherapy and chemoradiation
Chemoradiation	5-FU	Neoadjuvant chemotherapy and chemoradiation

Primary Outcome Measures

Name	Time	Method
Safety profile	5 years
Number of patients obtaining pCR	5 years

Secondary Outcome Measures

Name	Time	Method
Clinical, radiological and molecular response to treatment	5 years

Trial Locations

Locations (1)

RRHF; 🇳🇴 Oslo, Norway