Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006051
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2000-07-05
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility
Status:
COMPLETED
Status Verified Date:
2021-02
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:
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 more than one chemotherapy drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer
Detailed Description:
OBJECTIVES I Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection II Determine the efficacy of this regimen in these patients III Determine the survival of these patients treated with this regimen
OUTLINE This is a multicenter study Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2 23 and 44 Concurrent radiotherapy is administered 5 days a week for 65 weeks Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL A total of 44-68 patients will be accrued for this study within 18 months
OUTLINE This is a multicenter study Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2 23 and 44 Concurrent radiotherapy is administered 5 days a week for 65 weeks Patients are followed every 3 months for 2 years then every 6 months for 3 years
PROJECTED ACCRUAL A total of 44-68 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| EU-20015 | None | None | None |
| FRE-FNCLCC-GORTEC98-0198007 | None | None | None |