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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278694
First Posted: January 18, 2006
Last Update Posted: September 29, 2016
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.
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital
  Purpose
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxaliplatin and 5-FU Based Preoperative Chemoradiation

Resource links provided by NLM:


Further study details as provided by Svein Dueland, Oslo University Hospital:

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

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

Enrollment: 109
Study Start Date: September 2005
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoradiation
Neoadjuvant chemotherapy and chemoradiation
Drug: Oxaliplatin Drug: Chemoradiation Drug: 5-FU Radiation: Preoperative chemoradiation Procedure: Pelvic surgery Drug: Neoadjuvant oxaliplatin

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

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
  Contacts and Locations
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
  More Information