Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093665
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2004-10-06
Brief Title:
Fluorouracil Cisplatin and Radiation Therapy in Treating Patients With Stage II Stage III or Stage IV Nasopharyngeal Cancer
Sponsor:
Aichi Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Alternating Chemoradiotherapy For Nasopharyngeal Cancer Using Cisplatin And 5-Fluorouracil
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 fluorouracil and cisplatin work in 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 fluorouracil and cisplatin with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II stage III or stage IV nasopharyngeal cancer
PURPOSE This phase II trial is studying how well giving fluorouracil and cisplatin together with radiation therapy works in treating patients with stage II stage III or stage IV nasopharyngeal cancer
Detailed Description:
OBJECTIVES
Primary
Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil cisplatin and radiotherapy
Secondary
Determine overall survival and response rate in patients treated with this regimen
Determine compliance to this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7 Beginning 2-3 days after the completion of chemotherapy patients undergo radiotherapy once daily 5 days a week for 4 weeks With 2-3 days between each course patients receive a second course of chemotherapy undergo a second course of radiotherapy and then receive a third course of chemotherapy Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 2 years
Primary
Determine progression-free survival of patients with previously untreated stage IIB-IVB nasopharyngeal cancer treated with fluorouracil cisplatin and radiotherapy
Secondary
Determine overall survival and response rate in patients treated with this regimen
Determine compliance to this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive chemotherapy comprising fluorouracil IV continuously on days 1-5 and cisplatin IV continuously on days 6-7 Beginning 2-3 days after the completion of chemotherapy patients undergo radiotherapy once daily 5 days a week for 4 weeks With 2-3 days between each course patients receive a second course of chemotherapy undergo a second course of radiotherapy and then receive a third course of chemotherapy Treatment continues in the absence of unacceptable toxicity or disease progression
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 90 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| CDR0000389425 | REGISTRY | PDQ Physician Data Query | None |