Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113399
Status:
TERMINATED
Last Update Posted:
2013-07-02
First Post:
2005-06-07
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Trial for Locally Recurrent Previously Irradiated Head and Neck Cancer Concurrent Re-Irradiation and Chemotherapy Versus Chemotherapy Alone
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early due to low accrual
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 kill tumor cells Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Cisplatin and paclitaxel may make tumor cells more sensitive to radiation therapy Giving more than one drug combination chemotherapy and giving them with radiation therapy may kill more tumor cells It is not yet known whether giving radiation therapy together with combination chemotherapy is more effective than giving combination chemotherapy alone in treating head and neck cancer
PURPOSE This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery
PURPOSE This randomized phase III trial is studying radiation therapy and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating patients with recurrent head and neck cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy cisplatin and paclitaxel vs cisplatin-based chemotherapy alone
Secondary
Compare progression-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life functionalperformance status and quality-adjusted survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5 15-19 29-33 and 43-47 Patients also receive filgrastim G-CSF subcutaneously once daily on days 6-13 20-27 34-41 and 48-55
Arm II Patients receive 1 of the following cisplatin-based regimens at the discretion of the treating physician
Regimen 1 Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4
Regimen 2 Patients receive cisplatin IV over 1-2 hours and paclitaxel IV over 3 hours on day 1
Regimen 3 Patients receive cisplatin IV over 1-2 hours and docetaxel IV over 1 hour on day 1
NOTE Carboplatin may be substituted for cisplatin in patients with creatinine clearance 50 mLmin or in patients who experience grade 2 or 3 neurotoxicity
For all regimens treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond documentation of CR
Quality of life is assessed at baseline and then at 3 6 12 24 and 36 months
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm will be accrued for this study within 5½ years
Primary
Compare overall survival of patients with previously irradiated unresectable locally recurrent squamous cell carcinoma of the head and neck treated with radiotherapy cisplatin and paclitaxel vs cisplatin-based chemotherapy alone
Secondary
Compare progression-free survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life functionalperformance status and quality-adjusted survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy twice daily and receive paclitaxel IV over 1 hour and cisplatin IV over 30 minutes once daily on days 1-5 15-19 29-33 and 43-47 Patients also receive filgrastim G-CSF subcutaneously once daily on days 6-13 20-27 34-41 and 48-55
Arm II Patients receive 1 of the following cisplatin-based regimens at the discretion of the treating physician
Regimen 1 Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously over 96 hours on days 1-4
Regimen 2 Patients receive cisplatin IV over 1-2 hours and paclitaxel IV over 3 hours on day 1
Regimen 3 Patients receive cisplatin IV over 1-2 hours and docetaxel IV over 1 hour on day 1
NOTE Carboplatin may be substituted for cisplatin in patients with creatinine clearance 50 mLmin or in patients who experience grade 2 or 3 neurotoxicity
For all regimens treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond documentation of CR
Quality of life is assessed at baseline and then at 3 6 12 24 and 36 months
After completion of study treatment patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 240 patients 120 per treatment arm will be accrued for this study within 5½ 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 |
|---|---|---|---|
| ECOG-R0421 | None | None | None |
| CDR0000429480 | None | None | None |