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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00278694
First received: January 16, 2006
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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 2013
Primary Completion Date: May 2010 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Rectal cancer

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Svein Dueland, Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00278694     History of Changes
Other Study ID Numbers: S-05059, Eudractnr 2005-000024-16
Study First Received: January 16, 2006
Last Updated: May 29, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Oxaliplatin, radiation

Additional relevant MeSH terms:
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014