Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169182
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2005-09-09
Brief Title:
Induction CT by Cisplatin 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Sponsor:
Groupe Oncologie Radiotherapie Tete et Cou
Organization:
Groupe Oncologie Radiotherapie Tete et Cou
Study Overview
Official Title:
Randomized Study Comparing Induction Chemotherapy With Docetaxel Cisplatin 5FU Versus Cisplatin 5 FU in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-02
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:
The purpose of the study is to compare two regimen of chemotherapy used as first treatment for patients with larynx or hypopharynx tumors that would be treated with total laryngectomy The standard treatment is a combination of 2 drugs Cisplatin and 5FU The aim of the study is to evaluate the potential benefit of the addition of a third drug Docetaxel in the chemotherapy regimen Patients will receive 3 cycles of chemotherapy Responders to the induction treatment are treated with radiation with a purpose of larynx preservation Non responders patients will be treated with total laryngectomy
Detailed Description:
The purpose of the study is to compare two regimen of induction chemotherapy for patients with T3 and T4 larynx or hypopharynx carcinoma that would be treated with total laryngectomy The aim of the study is to compare the standard regimen Cisplatin 5FU versus the TPF regimen Taxotere Cisplatin 5FU Responders to the induction treatment are treated with radiation with a purpose of larynx preservation Non responders patients will be treated with total laryngectomy followed by postoperative radiation
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