Trial Outcomes & Findings for Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer (NCT NCT01856322)
NCT ID: NCT01856322
Last Updated: 2015-10-23
Results Overview
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.
TERMINATED
PHASE2
3 participants
3 years
2015-10-23
Participant Flow
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.
Participant milestones
| Measure |
Sulindac
one tablet twice daily
Sulindac: one tablet twice daily
|
Placebo
one tablet twice daily
Placebo: One tablet twice daily
|
Normal Volunteers (or Control Group)
Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Sulindac
one tablet twice daily
Sulindac: one tablet twice daily
|
Placebo
one tablet twice daily
Placebo: One tablet twice daily
|
Normal Volunteers (or Control Group)
Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
|
|---|---|---|---|
|
Overall Study
off study due to lack of accrual
|
0
|
0
|
3
|
Baseline Characteristics
Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Sulindac
one tablet twice daily
Sulindac: one tablet twice daily
|
Placebo
one tablet twice daily
Placebo: One tablet twice daily
|
Normal Volunteers (or Control Group)
n=3 Participants
Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
—
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Age, Continuous
|
—
|
—
|
72 years
STANDARD_DEVIATION 0 • n=206 Participants
|
72 years
STANDARD_DEVIATION 0 • n=7 Participants
|
|
Gender
Female
|
—
|
—
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Gender
Male
|
—
|
—
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
—
|
—
|
3 participants
n=206 Participants
|
3 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.
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.
Outcome measures
Outcome data not reported
Adverse Events
Sulindac
Placebo
Normal Volunteers (or Control Group)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place