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Trial record 3 of 4078 for:    colon cancer AND Intestinal Neoplasms

Surgery Plus Sulindac or Surgery Alone for Advanced 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: NCT01856322
Recruitment Status : Terminated (The trial was prematurely closed due to lack of accrual.)
First Posted : May 17, 2013
Results First Posted : May 7, 2015
Last Update Posted : October 23, 2015
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
Marybeth Hughes, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Conditions Colorectal Cancer
Liver Metastasis
Colorectal Adenocarcinoma
Interventions Drug: Sulindac
Drug: Placebo
Other: Validate assays and shipping methods
Enrollment 3
Recruitment Details  
Pre-assignment Details The normal volunteer (or control group) was not randomized to receive medication and was not considered evaluable. The control group purpose is to validate the assays and the shipping methods.
Arm/Group Title Sulindac Placebo Normal Volunteers (or Control Group)
Hide Arm/Group Description

one tablet twice daily

Sulindac: one tablet twice daily

one tablet twice daily

Placebo: One tablet twice daily

Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
Period Title: Overall Study
Started 0 0 3
Completed 0 0 0
Not Completed 0 0 3
Reason Not Completed
off study due to lack of accrual             0             0             3
Arm/Group Title Sulindac Placebo Normal Volunteers (or Control Group) Total
Hide Arm/Group Description

one tablet twice daily

Sulindac: one tablet twice daily

one tablet twice daily

Placebo: One tablet twice daily

Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method. Total of all reporting groups
Overall Number of Baseline Participants 0 0 3 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 3 participants 3 participants
<=18 years 0 0
Between 18 and 65 years 3 3
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 3 participants 3 participants
72  (0) 72  (0)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 3 participants 3 participants
Female 1 1
Male 2 2
Ethnicity (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 3 participants 3 participants
Hispanic or Latino 0 0
Not Hispanic or Latino 3 3
Unknown or Not Reported 0 0
Race (NIH/OMB)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 3 participants 3 participants
American Indian or Alaska Native 0 0
Asian 0 0
Native Hawaiian or Other Pacific Islander 0 0
Black or African American 2 2
White 1 1
More than one race 0 0
Unknown or Not Reported 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 3 participants 3 participants
3 3
1.Primary Outcome
Title Difference in Circulating S100A4 Transcript in Patients Receiving Sulindac 150 mg BD (Twice Daily) by Mouth Following Resection of Colorectal Cancer Metastases Compared to Those Who do Not.
Hide Description Difference in circulating S100A4 transcript levels will be determined by assessing the circulating S100A4 transcript level at initial presentation versus the circulating S100A4 transcript level post resection.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.
Arm/Group Title Sulindac Placebo
Hide Arm/Group Description:

one tablet twice daily

Sulindac: one tablet twice daily

one tablet twice daily

Placebo: One tablet twice daily

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sulindac Placebo Normal Volunteers (or Control Group)
Hide Arm/Group Description

one tablet twice daily

Sulindac: one tablet twice daily

one tablet twice daily

Placebo: One tablet twice daily

Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
All-Cause Mortality
Sulindac Placebo Normal Volunteers (or Control Group)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sulindac Placebo Normal Volunteers (or Control Group)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sulindac Placebo Normal Volunteers (or Control Group)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Marybeth Hughes
Organization: National Cancer Institute
Phone: 301-594-9341
Responsible Party: Marybeth Hughes, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01856322     History of Changes
Other Study ID Numbers: 130126
13-C-0126
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: March 25, 2015
Results First Posted: May 7, 2015
Last Update Posted: October 23, 2015