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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00278694
First received: January 16, 2006
Last updated: September 28, 2016
Last verified: September 2016
  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: 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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Number of patients obtaining pCR [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical, radiological and molecular response to treatment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Svein Dueland, Senior consultant medical oncology, Oslo University Hospital
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: September 28, 2016
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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 08, 2016