Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005087
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2000-04-06
Brief Title:
Paclitaxel Cisplatin and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2015-11
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 Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy Radiation therapy uses high-energy x-rays to damage tumor cells
PURPOSE Phase II trial to study the effectiveness of paclitaxel cisplatin and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy
PURPOSE Phase II trial to study the effectiveness of paclitaxel cisplatin and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy
Detailed Description:
OBJECTIVES
Determine the median one-year and long-term defined as two-year disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel cisplatin and filgrastim G-CSF combined with radiotherapy
Determine the rates of acute and late toxic effects of this regimen in these patients
Determine the pattern of disease progression in patients treated with this regimen
OUTLINE Patients undergo radiotherapy twice daily 4-6 hours apart on days 1-5 Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5 Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim G-CSF subcutaneously on days 6-13 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who initially respond to therapy but develop a recurrence with a resectable lesion inside or outside the retreatment field may undergo surgical resection
Patients are followed at 4 weeks after completion of radiotherapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 34 months
Determine the median one-year and long-term defined as two-year disease-free survival and overall survival in patients with previously irradiated locally recurrent squamous cell cancer of the head and neck treated with paclitaxel cisplatin and filgrastim G-CSF combined with radiotherapy
Determine the rates of acute and late toxic effects of this regimen in these patients
Determine the pattern of disease progression in patients treated with this regimen
OUTLINE Patients undergo radiotherapy twice daily 4-6 hours apart on days 1-5 Patients receive paclitaxel IV over 1 hour beginning immediately after completion of the first fraction of radiotherapy and completing less than 3 hours before starting the second fraction of radiotherapy on days 1-5 Patients receive cisplatin IV over 30 minutes beginning immediately after completion of paclitaxel infusion on days 1-5 and filgrastim G-CSF subcutaneously on days 6-13 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients who initially respond to therapy but develop a recurrence with a resectable lesion inside or outside the retreatment field may undergo surgical resection
Patients are followed at 4 weeks after completion of radiotherapy every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 100 patients will be accrued for this study within 34 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 |
|---|---|---|---|
| CDR0000067705 | None | None | None |