Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169221
Status:
TERMINATED
Last Update Posted:
2011-11-15
First Post:
2005-09-12
Brief Title:
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Organization:
Groupe Oncologie Radiotherapie Tete et Cou
Study Overview
Official Title:
CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 Iressa in Upper Aerodigestive Tract Carcinomas
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity in an independent study IMEX The trial was subsequently terminated 54 pts instead of 140 despite safety analyses showing no excess of toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas
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