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Trial record 23 of 104 for:    colon cancer | ( Map: Nebraska, United States )

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

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ClinicalTrials.gov Identifier: NCT01189227
Recruitment Status : Terminated (The study was terminated due to low accrual.)
First Posted : August 26, 2010
Results First Posted : March 15, 2013
Last Update Posted : May 10, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Cancer
Metastatic Cancer
Interventions Procedure: Postoperative chemotherapy
Procedure: Perioperative chemotherapy
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Postoperative Chemotherapy Arm 2: Perioperative Chemotherapy
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 6 3
Completed 0 0
Not Completed 6 3
Reason Not Completed
Study terminated due to low accrual             6             3
Arm/Group Title Postoperative Chemotherapy Perioperative Chemotherapy Total
Hide Arm/Group Description Postoperative chemotherapy Perioperative chemotherapy Total of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
64  (14.9) 55  (13.9) 61  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
5
  83.3%
0
   0.0%
5
  55.6%
Male
1
  16.7%
3
 100.0%
4
  44.4%
1.Primary Outcome
Title Recurrence-free Survival (RFS)
Hide Description Time to recurrence or death
Time Frame From study entry until the date of recurrence or death or for a maximum of 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Postoperative Chemotherapy Arm 2: Perioperative Chemotherapy
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title RFS of Patients Event-free
Hide Description [Not Specified]
Time Frame From study entry until the date of recurrence or for a maximum of 6 months.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From study entry until the time of death or for a maximum of 5 years.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Difference in R0 and Combined R0 + R1 Resection Rates Between the Two Arms.
Hide Description [Not Specified]
Time Frame Assessed at the time of surgery
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Frequencies of Selected Postoperative Surgical Complications and Other Adverse Events Within 30 Days of Surgery
Hide Description [Not Specified]
Time Frame Assessed within 30 days from the time of surgery
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Frequencies of Adverse Events as Assessed by the NCI CTCAE v4.0
Hide Description [Not Specified]
Time Frame From study entry through 3 months after the last treatment dose.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Participants at Risk includes any patient who submitted an AE form.
 
Arm/Group Title Postoperative Chemotherapy Perioperative Chemotherapy
Hide Arm/Group Description Postoperative chemotherapy Perioperative chemotherapy
All-Cause Mortality
Postoperative Chemotherapy Perioperative Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Postoperative Chemotherapy Perioperative Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   1/5 (20.00%)   0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  1/5 (20.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Postoperative Chemotherapy Perioperative Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   3/5 (60.00%)   1/2 (50.00%) 
Blood and lymphatic system disorders     
Anemia  1  1/5 (20.00%)  0/2 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/5 (0.00%)  1/2 (50.00%) 
Diarrhea  1  1/5 (20.00%)  0/2 (0.00%) 
Mucositis oral  1  1/5 (20.00%)  0/2 (0.00%) 
Nausea  1  1/5 (20.00%)  0/2 (0.00%) 
General disorders     
Fatigue  1  1/5 (20.00%)  0/2 (0.00%) 
Investigations     
Alkaline phosphatase increased  1  1/5 (20.00%)  0/2 (0.00%) 
Neutrophil count decreased  1  1/5 (20.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  1/5 (20.00%)  0/2 (0.00%) 
Dehydration  1  1/5 (20.00%)  0/2 (0.00%) 
Hypokalemia  1  1/5 (20.00%)  0/2 (0.00%) 
Nervous system disorders     
Paresthesia  1  1/5 (20.00%)  0/2 (0.00%) 
Peripheral motor neuropathy  1  1/5 (20.00%)  0/2 (0.00%) 
Peripheral sensory neuropathy  1  1/5 (20.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/5 (20.00%)  0/2 (0.00%) 
Hypoxia  1  1/5 (20.00%)  0/2 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
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.
Results Point of Contact
Name/Title: Director, Division of Regulatory Affairs
Organization: NSABP Foundation, Inc.
Phone: 412-330-4600
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT01189227     History of Changes
Other Study ID Numbers: NSABP C-11
NSABP-C-11
First Submitted: August 25, 2010
First Posted: August 26, 2010
Results First Submitted: February 5, 2013
Results First Posted: March 15, 2013
Last Update Posted: May 10, 2013