Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232453
Status:
COMPLETED
Last Update Posted:
2011-02-15
First Post:
2005-10-03
Brief Title:
Preoperative Combined Radiation and Chemotherapy - Rectal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is no established standard preoperative treatment in rectal cancer Two large randomized studies in North America closed from lack of accrual therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy The current standard at PMH is preoperative radiation 46Gy in 23 fractions with concurrent 5FU infusion 225mgm2 An increase of radiation dose and consequent increase in chemotherapy may improve the response rate but may also increase toxicity It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None