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

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. Identifier: NCT00803647
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : September 14, 2016
Last Update Posted : May 7, 2018
Bristol-Myers Squibb
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Biological: cetuximab
Drug: 5-FU
Drug: oxaliplatin
Drug: leucovorin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Treatment mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab

Participant Flow:   Overall Study

  Baseline Characteristics

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 52.8  (8.4) 
Sex/Gender, Customized [1] 
[Units: Participants]
 NA [1] 
[1] Gender data were not collected.
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
Hispanic or Latino      2  10.0% 
Not Hispanic or Latino      18  90.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      0   0.0% 
Asian      2  10.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      18  90.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  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:   Overall Survival (OS). Time From Study Entry Until Death From Any Cause.   [ Time Frame: 18 months ]

4.  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 ]

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Responsible Party: NSABP Foundation Inc Identifier: NCT00803647     History of Changes
Other Study ID Numbers: NSABP FC-6
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: October 19, 2015
Results First Posted: September 14, 2016
Last Update Posted: May 7, 2018