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

This study is ongoing, but not recruiting participants.
Information provided by:
Oslo University Hospital Identifier:
First received: January 16, 2006
Last updated: November 4, 2014
Last verified: November 2014
Oxaliplatin and 5FU based preoperative chemoradiation in rectal cancer.

Condition Intervention Phase
Rectal Cancer
Drug: Oxaliplatin and 5-FU based preoperative chemoradiation
Drug: Chemoradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Oslo University Hospital:

Primary Outcome Measures:
  • Safety profile [ Designated as safety issue: Yes ]
  • Number of patients obtaining pCR [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical, radiological and molecular response to treatment [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2005
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemoradiation Drug: Oxaliplatin and 5-FU based preoperative chemoradiation Drug: Chemoradiation

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Rectal cancer
  Contacts and Locations
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Please refer to this study by its identifier: NCT00278694

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Svein Dueland, Rikshospitalet-Radiumhospitalet HF Identifier: NCT00278694     History of Changes
Other Study ID Numbers: S-05059  Eudractnr 2005-000024-16 
Study First Received: January 16, 2006
Last Updated: November 4, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Oxaliplatin, radiation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on September 28, 2016