Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025298
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2001-10-11
Brief Title:
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer UNPC
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 radiation therapy with chemotherapy may kill more tumor cells Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy
PURPOSE Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx
PURPOSE Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx
Detailed Description:
OBJECTIVES
Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine
Compare the feasibility and activity of these regimens in these patients
Determine the toxicity of paclitaxel and carboplatin in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to WHO performance status 0 vs 1 vs 2 response to induction chemotherapy complete vs partial vs stable disease vs not evaluable and participating center
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV on days 1 22 and 43 Patients also undergo radiotherapy daily 5 days a week for 65 weeks
Arm IIPatients receive amifostine subcutaneously daily Patients receive chemotherapy and radiotherapy as in arm I
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 41-93 patients will be accrued for this study
Compare the overall incidence of grade 3 or 4 mucositis in patients with locally advanced undifferentiated nasopharyngeal cancer treated with paclitaxel and carboplatin followed by cisplatin and radiotherapy with or without amifostine
Compare the feasibility and activity of these regimens in these patients
Determine the toxicity of paclitaxel and carboplatin in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to WHO performance status 0 vs 1 vs 2 response to induction chemotherapy complete vs partial vs stable disease vs not evaluable and participating center
Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Patients with a complete or partial response after 2 courses of induction chemotherapy receive 2 additional courses before randomization Patients with stable disease after 2 courses of induction chemotherapy or who cannot be evaluated after 1 course proceed directly to randomization Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cisplatin IV on days 1 22 and 43 Patients also undergo radiotherapy daily 5 days a week for 65 weeks
Arm IIPatients receive amifostine subcutaneously daily Patients receive chemotherapy and radiotherapy as in arm I
Patients are followed every 3 months for 2 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 41-93 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-24981 | None | None | None |