Oxaliplatin and 5-FU Based Preoperative Chemoradiation (LARC-RRP)

September 28, 2016 updated by: Svein Dueland, Oslo University Hospital
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • RRHF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Rectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiation
Neoadjuvant chemotherapy and chemoradiation
Drug: Oxaliplatin
Drug: 5-FU
Drug: Chemoradiation
Procedure: Pelvic surgery
Radiation: Preoperative chemoradiation
Drug: Neoadjuvant oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile
Time Frame: 5 years
5 years
Number of patients obtaining pCR
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical, radiological and molecular response to treatment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Investigators

  • Study Chair: Georg Høyer, DH, South region committee for research ethics in Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria

January 16, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-05059
  • Eudractnr 2005-000024-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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