Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422864
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2007-01-15
Brief Title:
A Single Arm Trial of Oxaliplatin and 5FU With Concurrent Radiation in Patients With Metastatic Rectal Cancer
Sponsor:
Peter MacCallum Cancer Centre Australia
Organization:
Peter MacCallum Cancer Centre Australia
Study Overview
Official Title:
A Single-Arm Prospective Trial Evaluating The Local And Systemic Benefits Of Oxaliplatin And 5FU With Concurrent Radiation In Patients With Metastatic Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2011-09
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:
This trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum The aims of the trial are 1 to determine the tolerability rate and 2 to determine toxicity rates pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy oxaliplatin5-fluorouracil 5FU and radiotherapy regimen
Detailed Description:
Week 1 Oxaliplatin 100 mgm2 Day 1 over 2 hours leucovorin 200mgm2 Day 1 concurrent with oxaliplatin over 2 hrs then 5-FU 400mgm2 bolus Day 1 then 5-FU continuous infusion 24 gm2 over 46 hours from Day 1
Weeks 3 to 5 radiotherapy 252 Gy in 14 fractions over 3 weeks with 85 mgm2 oxaliplatin on the first day and continuous infusion 5-FU 200 mgm2day on the days of radiotherapy
Week 6 as per Week 1
Weeks 8-10 as per Weeks 3-5
Weeks 11 as per Week 1
Weeks 3 to 5 radiotherapy 252 Gy in 14 fractions over 3 weeks with 85 mgm2 oxaliplatin on the first day and continuous infusion 5-FU 200 mgm2day on the days of radiotherapy
Week 6 as per Week 1
Weeks 8-10 as per Weeks 3-5
Weeks 11 as per Week 1
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