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A Study With Neoadjuvant mFOLFOX7 Plus Cetuximab to Determine the Surgical Conversion Rate for Unresectable Colorectal Cancer With Metastases Confined to the Liver

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00803647
First received: December 4, 2008
Last updated: July 26, 2016
Last verified: July 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Biological: cetuximab
Drug: 5-FU
Drug: oxaliplatin
Drug: leucovorin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab

Participant Flow:   Overall Study
    Treatment
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.8  (8.4) 
Gender, Customized [1] 
[Units: Participants]
 NA [1] 
[1] Gender data were not collected.
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   18 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   18 
More than one race   0 
Unknown or Not Reported   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Patients Who Had a Curative (R0) Liver Metastasectomy Following Protocol Treatment, i.e., Metastatic Disease That Can be Completely Resected and/or Ablated With no Postoperative Evidence of Residual Malignant Disease (R0 Resection).   [ Time Frame: 8 months ]

2.  Primary:   Reported Adverse Events.   [ Time Frame: 8 months ]

3.  Secondary:   Objective Clinical Response Rate (cRR). Measureable Lesions That Can be Accurately Measured in at Least One Dimension With Conventional Radiologic Techniques or Spiral CT.   [ Time Frame: 8 months ]

4.  Secondary:   Recurrence-free Survival (RFS). Time From Study Entry Until First Recurrence.   [ Time Frame: 2 years ]

5.  Secondary:   Overall Survival (OS). Time From Study Entry Until Death From Any Cause.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Diana Gosik, Director Department of Site and Study Management
Organization: NSABP Foundation
phone: 412-339-5333
e-mail: diana.gosik@nsabp.org



Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00803647     History of Changes
Other Study ID Numbers: NSABP FC-6
Study First Received: December 4, 2008
Results First Received: October 19, 2015
Last Updated: July 26, 2016
Health Authority: United States: Institutional Review Board