Trial Outcomes & Findings for Neo-Adjuvant FOLFOX for Rectal Carcinoma (NCT NCT00832299)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

3-6 months

Results posted on

2018-03-01

Subjects were recruited from the GI Oncology practice.

Participant milestones
Measure	6 Cycles of FOLFOX Pre and Post TME total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX. FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Neo-Adjuvant FOLFOX for Rectal Carcinoma

Baseline characteristics by cohort
Measure	6 Cycles of FOLFOX Pre and Post TME n=2 Participants total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX. FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

Timeframe: 3-6 months

Population: Study terminated prior to data collection of time frame

Outcome data not reported

Timeframe: 5 years

Population: Data not collected

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Beth Israel Medical Center