Neo-Adjuvant FOLFOX for Rectal Carcinoma

Summary

A Phase II open- labeled, prospective study to determine the efficacy of pre-operative chemotherapy with six cycles of modified FOLFOX 6 followed by total mesorectal excision (TME) followed by an additional six cycles of FOLFOX 6. The objectives of this study are the following: 1. The primary endpoint of this trial is pathologic complete response (response rate). 2. Secondary endpoints will include observation of overall pathologic response rate, correlation of pathologic staging with pre-operative ultrasound and pelvic MRI staging, as well as observation of toxic side effects, patterns of disease relapse, disease-free survival outcomes and overall survival outcomes.

Timeline

Start

2009-01

Primary completion

2011-08

Completion

2011-08

Outcome

Outcome not reported

Stopped (Enrollment): “terminated for lack of enrollment”

Drugs

Indications