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Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer

Clinical Trial Summary

This study will assess the complete clinical response (no clinical evidence of remaining disease or recurrence of disease)in rectal cancer that arises within 3 inches of the anal opening after radiation therapy given at the same time as chemotherapy over a 6 week period, followed by chemotherapy alone given three times over an additional 9 weeks. Follow-up begins with an examination at the end of treatment (at 15 weeks), with ongoing follow-up every 4-6 weeks for one year.

Clinical Trial Description

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 performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01613469
Study type Interventional
Source Marks, John, M.D.
Contact
Status Terminated
Phase Phase 2
Start date August 2011
Completion date March 16, 2017
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