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Chemotherapy With DNA Damaging Agents In Colorectal Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01456923
Recruitment Status : Completed
First Posted : October 21, 2011
Last Update Posted : October 21, 2011
Sponsor:
Information provided by (Responsible Party):
Ana Cadavez Pedro, Centro Hospitalar Nordeste

Tracking Information
First Submitted Date  ICMJE October 18, 2011
First Posted Date  ICMJE October 21, 2011
Last Update Posted Date October 21, 2011
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy With DNA Damaging Agents In Colorectal Cancer
Official Title  ICMJE Phase 1 Study Of The Efficacy Of Chemotherapy With DNA Damaging Agents Versus Surgery In Colorectal Cancer
Brief Summary Chemotherapy Treatment alone with DNA damaging drugs might be as effective as chemotherapy combined with surgery in colorectal cancer (CRC) avoiding surgery complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Other: Treatment with chemotherapy
  • Other: Only chemotherapy treatment for study cohort
    Control patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy
  • Procedure: surgery
Study Arms  ICMJE
  • Active Comparator: Control (chemotherapy and surgery)
    Patients treated with chemotherapy + surgery
    Interventions:
    • Other: Treatment with chemotherapy
    • Procedure: surgery
  • Active Comparator: Study
    Patients treated only with chemotherapy
    Intervention: Other: Only chemotherapy treatment for study cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

- patients that did not underwent surgery

Exclusion Criteria:

- patients that underwent surgery

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01456923
Other Study ID Numbers  ICMJE ACCRC10
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Cadavez Pedro, Centro Hospitalar Nordeste
Study Sponsor  ICMJE Centro Hospitalar Nordeste
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centro Hospitalar Nordeste
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP