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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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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