Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017277
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2001-06-06
Brief Title:
Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Head and Neck Cancer
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 Phase III Double-Blind Randomized Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma
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 Radiation therapy uses high-energy x-rays to damage tumor cells Epoetin alfa may help prevent or treat cancer-related anemia It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of radiotherapy in terms of local-regional control with or without epoetin alfa in patients with squamous cell carcinoma of the head and neck
Compare the disease-specific and overall survival of patients treated with these regimens
Compare the hemoglobin level of these patients during radiotherapy
Compare the acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center site of disease larynx vs hypopharynx vs oropharynx vs oral cavity T-classification T1-2 vs T3-4 N-classification and intent of systematic neck node dissection N0-1 vs N2-3 without node dissection vs N2-3 with node dissection hemoglobin level and gender men with 10-125 gdL vs men with 125-14 gdL vs women with 10-12 gdL vs women with 12-135 gdL and type of treatment EORTC standard vs other vs randomized in other trials Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo standard radiotherapy 5 days a week and receive concurrent epoetin alfa subcutaneously SC once weekly
Arm II Patients undergo radiotherapy as in arm I and receive concurrent placebo SC once weekly
Treatment on both arms continues for 6-8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3-6 weeks and 9-14 weeks every 3 months for 2 years every 6 months for 1 year and then annually thereafter After any locoregional recurrence patients are followed every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study within 3 years
Compare the efficacy of radiotherapy in terms of local-regional control with or without epoetin alfa in patients with squamous cell carcinoma of the head and neck
Compare the disease-specific and overall survival of patients treated with these regimens
Compare the hemoglobin level of these patients during radiotherapy
Compare the acute and late toxic effects of these regimens in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to participating center site of disease larynx vs hypopharynx vs oropharynx vs oral cavity T-classification T1-2 vs T3-4 N-classification and intent of systematic neck node dissection N0-1 vs N2-3 without node dissection vs N2-3 with node dissection hemoglobin level and gender men with 10-125 gdL vs men with 125-14 gdL vs women with 10-12 gdL vs women with 12-135 gdL and type of treatment EORTC standard vs other vs randomized in other trials Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo standard radiotherapy 5 days a week and receive concurrent epoetin alfa subcutaneously SC once weekly
Arm II Patients undergo radiotherapy as in arm I and receive concurrent placebo SC once weekly
Treatment on both arms continues for 6-8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3-6 weeks and 9-14 weeks every 3 months for 2 years every 6 months for 1 year and then annually thereafter After any locoregional recurrence patients are followed every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 800 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| GELCB-EORTC-22996 | None | None | None |
| EORTC-22996 | None | None | None |
| ARO-EORTC-22996 | None | None | None |
| EORTC-HN-22996 | None | None | None |
| GORTEC-EORTC-22996 | None | None | None |
| TROG-EORTC-22996 | None | None | None |
| RHOG-EORTC-22996 | None | None | None |