Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01613469
Status:
TERMINATED
Last Update Posted:
2018-08-16
First Post:
2012-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maintenance Chemotherapy After Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Sponsor:
Marks, John, M.D.
Organization:
Study Overview
Official Title:
Maintenance of Chemotherapy Following Neoadjuvant Chemoradiation Therapy for Distal Rectal Cancer
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Re-eval of patient population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: