Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213486
Status:
COMPLETED
Last Update Posted:
2005-10-28
First Post:
2005-09-13
Brief Title:
Weekly CisplatinIrinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer Phase II Trial
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Weekly CisplatinIrinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer Phase II Trial
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival
Detailed Description:
Chemotherapy with weekly cisplatin 30 mgm2 AND Irinotecan 60 mgm2 was administered at days182229 and concurrently with radiotherapy t days 43506471 Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions5 weeks
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