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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00278694
Recruitment Status : Completed
First Posted : January 18, 2006
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

Brief Summary:
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Oxaliplatin Drug: Chemoradiation Drug: 5-FU Radiation: Preoperative chemoradiation Procedure: Pelvic surgery Drug: Neoadjuvant oxaliplatin Phase 2

Detailed Description:
Effect of treatment, safety profile and quality of life scorings.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxaliplatin and 5-FU Based Preoperative Chemoradiation
Study Start Date : September 2005
Primary Completion Date : February 2016
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Safety profile [ Time Frame: 5 years ]
  2. Number of patients obtaining pCR [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Clinical, radiological and molecular response to treatment [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Rectal cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278694


Locations
Norway
RRHF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Georg Høyer, DH South region committee for research ethics in Norway