Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084435
Status:
WITHDRAWN
Last Update Posted:
2012-06-14
First Post:
2004-06-10
Brief Title:
S0217 Adjuvant Cisplatin and Docetaxel After Complete Resection Stage III or IV Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Adjuvant Chemo-RT With Cisplatin NSC-119875 and Docetaxel NSC-628503 After Complete Resection of Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual and suspension of head and neck committee
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
S0217
Brief Summary:
RATIONALE Drugs used in chemotherapy such as cisplatin and docetaxel 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 Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy Giving chemoradiotherapy after surgery may kill any remaining tumor cells
PURPOSE This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer
PURPOSE This phase II trial is studying how well adjuvant chemoradiotherapy using cisplatin and docetaxel works in treating patients with completely resected stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin
Determine the toxicity of this regimen in these patients
Categorize the sites of disease relapse in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 and 36 and cisplatin IV over 15 hours on days 1 22 and 43 Patients undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-45 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 175-235 months
Determine the disease-free survival and overall survival of patients with high-risk stage III or IV squamous cell carcinoma of the head and neck treated with adjuvant chemoradiotherapy comprising docetaxel and cisplatin
Determine the toxicity of this regimen in these patients
Categorize the sites of disease relapse in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour on days 1 8 15 22 29 and 36 and cisplatin IV over 15 hours on days 1 22 and 43 Patients undergo radiotherapy once daily on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-45 Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration
PROJECTED ACCRUAL A total of 70 patients will be accrued for this study within 175-235 months
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 |
|---|---|---|---|
| S0217 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |