Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054054
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2003-02-05
Brief Title:
S0216 Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Docetaxel NSC-628503 Cisplatin NSC-119875 And 5-Fluorouracil NSC-19893 Induction Chemotherapy Followed By Accelerated FractionationConcomitant Boost Radiation And Concurrent Single Agent Cisplatin NSC-119875 In Patients With Advanced Squamous Cell Head And Neck Cancer
Status:
COMPLETED
Status Verified Date:
2011-07
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 and radiation therapy in treating patients with stage III or stage IV head and neck cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel cisplatin and fluorouracil followed by accelerated fractionationconcomitant boost radiotherapy and cisplatin
Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy
Determine the overall complete response rate confirmed and unconfirmed in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE
Induction Chemotherapy Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity
Chemoradiotherapy Beginning within 3-4 weeks after administration of the second course of induction chemotherapy patients receive accelerated fractionation radiotherapy once daily 5 days per week for 6 weeks with concomitant boost radiotherapy once daily 5 days a week for the last 25 weeks of radiotherapy Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22
Patients are followed every 2 months for 1 year every 3 months for 2 years every 4 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
Determine the overall survival of patients with stage III or IV squamous cell head and neck cancer treated with docetaxel cisplatin and fluorouracil followed by accelerated fractionationconcomitant boost radiotherapy and cisplatin
Determine the unconfirmed complete response rate in these patients after treatment with induction chemotherapy
Determine the overall complete response rate confirmed and unconfirmed in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE
Induction Chemotherapy Patients receive docetaxel IV over 1 hour and cisplatin IV over 30-60 minutes on day 1 and fluorouracil IV continuously on days 1-4 Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity
Chemoradiotherapy Beginning within 3-4 weeks after administration of the second course of induction chemotherapy patients receive accelerated fractionation radiotherapy once daily 5 days per week for 6 weeks with concomitant boost radiotherapy once daily 5 days a week for the last 25 weeks of radiotherapy Patients also receive concurrent cisplatin IV over 30-60 minutes on days 1 and 22
Patients are followed every 2 months for 1 year every 3 months for 2 years every 4 months for 1 year and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0216 | OTHER | None | None |