Trial Outcomes & Findings for Surgery Plus Sulindac or Surgery Alone for Advanced Colorectal Cancer (NCT 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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

3 years

Results posted on

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

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

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

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=5 Participants	0 participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	—	3 participants n=5 Participants	3 participants n=4 Participants
Age, Categorical >=65 years	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Age, Continuous	—	—	72 years STANDARD_DEVIATION 0 • n=5 Participants	72 years STANDARD_DEVIATION 0 • n=4 Participants
Gender Female	—	—	1 participants n=5 Participants	1 participants n=4 Participants
Gender Male	—	—	2 participants n=5 Participants	2 participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	3 participants n=5 Participants	3 participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Race (NIH/OMB) Asian	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Race (NIH/OMB) Black or African American	—	—	2 participants n=5 Participants	2 participants n=4 Participants
Race (NIH/OMB) White	—	—	1 participants n=5 Participants	1 participants n=4 Participants
Race (NIH/OMB) More than one race	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Region of Enrollment United States	—	—	3 participants n=5 Participants	3 participants n=4 Participants

PRIMARY outcome

Timeframe: 3 years

Population: The trial was prematurely closed due to lack of accrual, thus the outcome measure was not met.

Outcome measures

Outcome data not reported

Adverse Events

Sulindac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Volunteers (or Control Group)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marybeth Hughes

National Cancer Institute

Phone: 301-594-9341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place