Trial record 1 of 1 for:    nsabp AND nci AND c-11
Previous Study | Return to List | Next Study

Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery

This study has been terminated.
(The study was terminated due to low accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT01189227
First received: August 25, 2010
Last updated: May 8, 2013
Last verified: May 2013
Results First Received: February 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colorectal Cancer
Metastatic Cancer
Interventions: Procedure: Postoperative chemotherapy
Procedure: Perioperative chemotherapy

  Participant Flow
  Hide Participant Flow

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
Arm 1: Postoperative Chemotherapy Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
Arm 2: Perioperative Chemotherapy Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.

Participant Flow:   Overall Study
    Arm 1: Postoperative Chemotherapy     Arm 2: Perioperative Chemotherapy  
STARTED     6     3  
COMPLETED     0     0  
NOT COMPLETED     6     3  
Study terminated due to low accrual                 6                 3  



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Postoperative Chemotherapy Postoperative chemotherapy
Perioperative Chemotherapy Perioperative chemotherapy
Total Total of all reporting groups

Baseline Measures
    Postoperative Chemotherapy     Perioperative Chemotherapy     Total  
Number of Participants  
[units: participants]
  6     3     9  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 14.9     55  ± 13.9     61  ± 14.4  
Gender  
[units: participants]
     
Female     5     0     5  
Male     1     3     4  



  Outcome Measures

1.  Primary:   Recurrence-free Survival (RFS)   [ Time Frame: From study entry until the date of recurrence or death or for a maximum of 5 years. ]

2.  Secondary:   RFS of Patients Event-free   [ Time Frame: From study entry until the date of recurrence or for a maximum of 6 months. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Overall Survival   [ Time Frame: From study entry until the time of death or for a maximum of 5 years. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.   [ Time Frame: Assessed at the time of surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery   [ Time Frame: Assessed within 30 days from the time of surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0   [ Time Frame: From study entry through 3 months after the last treatment dose. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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 more than 60 days but less than or equal to 180 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: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
phone: 412-330-4600


No publications provided


Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT01189227     History of Changes
Other Study ID Numbers: NSABP C-11, NSABP-C-11
Study First Received: August 25, 2010
Results First Received: February 5, 2013
Last Updated: May 8, 2013
Health Authority: United States: Federal Government