Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006107
Status:
COMPLETED
Last Update Posted:
2017-06-16
First Post:
2000-08-03
Brief Title:
Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Taxotere Plus Concurrent Concomitant Boost Radiotherapy For Squamous Cell Cancer of the Head and Neck TAXT-XRT
Status:
COMPLETED
Status Verified Date:
2017-06
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:
Phase I trial to study the effectiveness of docetaxel plus radiation therapy in treating patients who have stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy
Determine the toxicity of this treatment regimen in this patient population
Determine the efficacy of this treatment regimen in these patients
OUTLINE This is a dose escalation study of docetaxel
Patients receive docetaxel IV over 1 hour weekly for 4 weeks Patients also undergo hyperfractionated radiotherapy daily 5 days a week for 4 weeks followed by radiotherapy alone twice daily for 2 weeks
Upon completion of chemoradiotherapy patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is reached The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity Additional patients are treated at the MTD
Patients are followed monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 18-25 patients will be accrued for this study
Determine the maximum tolerated dose of docetaxel when administered with concurrent boost radiotherapy in patients with advanced squamous cell carcinoma of the head and neck previously treated with induction chemotherapy
Determine the toxicity of this treatment regimen in this patient population
Determine the efficacy of this treatment regimen in these patients
OUTLINE This is a dose escalation study of docetaxel
Patients receive docetaxel IV over 1 hour weekly for 4 weeks Patients also undergo hyperfractionated radiotherapy daily 5 days a week for 4 weeks followed by radiotherapy alone twice daily for 2 weeks
Upon completion of chemoradiotherapy patients not achieving complete response to induction chemotherapy undergo neck surgical dissection at 4-12 weeks following completion of radiotherapy
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is reached The MTD is the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose limiting toxicity Additional patients are treated at the MTD
Patients are followed monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 18-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1833 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |