Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243113
Status:
COMPLETED
Last Update Posted:
2013-03-26
First Post:
2005-10-20
Brief Title:
Docetaxel and Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Larynx or Hypopharynx
Sponsor:
Aichi Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Multi-Institutional Phase II Study of Weekly Docetaxel and Concurrent Radiotherapy for Laryngeal and Hypopharyngeal Cancer in the Group of Elderly andor Patients With Medical Illness
Status:
COMPLETED
Status Verified Date:
2008-03
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:
RATIONALE Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving docetaxel together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx
PURPOSE This phase II trial is studying how well giving docetaxel together with radiation therapy works in treating patients with stage II or stage III cancer of the larynx or hypopharynx
Detailed Description:
OBJECTIVES
Primary
Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy
Secondary
Determine the local relapse-free survival of patients treated with this regimen
Determine the larynx-preservation survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the protocol completion rate in patients treated with this regimen
Determine the adverse effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on days 1 8 15 22 and 29 and undergo radiotherapy on days 1-5 8-12 15-19 22-26 and 29-33
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
Primary
Determine the objective response of the primary tumor in patients with stage II or III squamous cell carcinoma of the larynx or hypopharynx treated with docetaxel and radiotherapy
Secondary
Determine the local relapse-free survival of patients treated with this regimen
Determine the larynx-preservation survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the protocol completion rate in patients treated with this regimen
Determine the adverse effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on days 1 8 15 22 and 29 and undergo radiotherapy on days 1-5 8-12 15-19 22-26 and 29-33
PROJECTED ACCRUAL A total of 25-50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AICHI-UHA-HN04-02 | None | None | None |