Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Research has shown that low rectal cancer treated with neoadjuvant chemoradiation (54Gy
concurrent with 3 cycles of 5-FU/Leucovorin) followed by 3 additional cycles of
5FU/Leucovorin, followed by close follow-up (every 4-6 weeks for one year)has had good
success in achieving complete clinical response, avoiding surgical intervention. If at
follow-up remaining disease is found or if there is recurrent disease, surgery can be
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the complete clinical response rate following neoadjuvant chemoradiation in patients with distal rectal cancer.
Primary endpoints are the proportion of subjects with complete clinical response to chemoradiation therapy at no sooner than 9 weeks from treatment completion, and maintenance of continuous freedom from local failure for one year.
One year from the time of chemoradiation
John Marks, MD
Main Line Health
United States: Food and Drug Administration
|Lankenau Medical Center||Wynnewood, Pennsylvania 19096|