Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002951
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Hyperfractionated Radiotherapy With Concomitant Fluorouracil and Hydroxurea for Intermediate Stage Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-09
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with head and neck cancer
Detailed Description:
OBJECTIVES
Determine the locoregional control rates time to failure need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity pharynx larynx paranasal sinuses and cervical esophagus
Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation organ function and quality of life parameters
Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring
OUTLINE Patients receive concomitant chemoradiotherapy with curative intent Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5 Fluorouracil is given IV on days 0-4 Radiation therapy BID is given on days 1-6 Cycles repeat every 14 days for a total of 5 cycles
The disease will be reevaluated 4-6 weeks after completion of all treatment every 3 months for 1 year then yearly
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
Determine the locoregional control rates time to failure need for salvage surgery and overall survival of patients with intermediate stage cancer of the oral cavity pharynx larynx paranasal sinuses and cervical esophagus
Measure the impact of concomitant Hyper-FHX radiotherapy on organ preservation organ function and quality of life parameters
Identify possible prognostic factors for toxic effects and response by performing pharmacologic monitoring
OUTLINE Patients receive concomitant chemoradiotherapy with curative intent Patients who have microscopic or macroscopic residual disease 6 weeks after completion of chemoradiotherapy will receive a surgical salvage procedure
The first cycle of chemotherapy will begin with PO doses of hydroxyurea every 12 hours on days 0-5 Fluorouracil is given IV on days 0-4 Radiation therapy BID is given on days 1-6 Cycles repeat every 14 days for a total of 5 cycles
The disease will be reevaluated 4-6 weeks after completion of all treatment every 3 months for 1 year then yearly
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1159 | None | None | None |
| UCCRC-8176 | None | None | None |
| NU-V96N1 | None | None | None |