Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003576
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery
Sponsor:
National Cancer Centre Singapore
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable Non-Metastatic Stage IIIIV Head and Neck Squamous Cell Cancer
Status:
COMPLETED
Status Verified Date:
2007-04
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer
PURPOSE This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery
PURPOSE This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery
Detailed Description:
OBJECTIVES
Compare the complete response rate disease-free survival and overall survival of patients with resectable nonmetastatic stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy
OUTLINE This is a randomized study Patients are stratified according to primary site of disease oral cavityoropharynx vs larynxhypopharynx vs others and nodal status node negative vs positive
Arm I Patients undergo resection of the tumor followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day 5 days a week for 6 weeks
Arm II Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin Radiotherapy is given once a day 5 days a week for 65 weeks to the primary tumor and upper neck Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy A second course of fluorouracil and cisplatin is given on day 28
Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery
Patients are followed once a month for the first year every 2 months for the second year every 3 months for the third year and every 6 months thereafter
PROJECTED ACCRUAL Approximately 200 patients will be accrued over a 4-5 year period
Compare the complete response rate disease-free survival and overall survival of patients with resectable nonmetastatic stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy
OUTLINE This is a randomized study Patients are stratified according to primary site of disease oral cavityoropharynx vs larynxhypopharynx vs others and nodal status node negative vs positive
Arm I Patients undergo resection of the tumor followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day 5 days a week for 6 weeks
Arm II Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin Radiotherapy is given once a day 5 days a week for 65 weeks to the primary tumor and upper neck Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy A second course of fluorouracil and cisplatin is given on day 28
Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery
Patients are followed once a month for the first year every 2 months for the second year every 3 months for the third year and every 6 months thereafter
PROJECTED ACCRUAL Approximately 200 patients will be accrued over a 4-5 year period
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 |
|---|---|---|---|
| NMRC-SHN01 | None | None | None |
| EU-97015 | None | None | None |