Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004917
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2000-03-07
Brief Title:
Radiation Therapy With or Without Epoetin Alfa in Treating Anemic Patients With Head and Neck Cancer
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Randomized Phase III Trial to Assess the Effect of Erythropoietin on Local-Regional Control in Anemic Patients Treated With Radiotherapy for Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2016-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells Epoetin alfa may stimulate red blood cell production and treat anemia in patients with head and neck cancer It is not yet known whether receiving radiation therapy with epoetin alfa is more effective than radiation therapy alone in treating anemic patients with head and neck cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating anemic 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 anemic patients who have head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck
Secondary
Determine whether this drug improves survival in this patient population
Identify patterns in first failure in these patients
Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients
Assess the toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are stratified according to stage III vs IIIIV without chemotherapy vs IIIIV with chemotherapy pretreatment hemoglobin level 90 to less than 115 gdL vs 115 to 135 gdL and gender Patients are randomized to one of two treatment arms
Arm I Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks Patients with stage III or IV disease undergo radiotherapy once daily for 35 weeks and then twice daily 6 hours apart for 25 weeks for a total of 6 weeks
Arm II Patients undergo radiotherapy as in arm I Beginning 7-10 days before radiotherapy patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy
Patients with stage IIIIV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 372 patients 186 per arm will be accrued for this study within 35 years
Primary
Determine whether epoetin alfa given during definitive radiotherapy or chemoradiotherapy improves the local-regional control rate in anemic patients with squamous cell carcinoma of the head and neck
Secondary
Determine whether this drug improves survival in this patient population
Identify patterns in first failure in these patients
Determine whether there is a significant increase in hemoglobin level between the baseline value and the value at 28 days after starting epoetin alfa in these patients
Assess the toxicity of this regimen in these patients
OUTLINE This is a randomized study Patients are stratified according to stage III vs IIIIV without chemotherapy vs IIIIV with chemotherapy pretreatment hemoglobin level 90 to less than 115 gdL vs 115 to 135 gdL and gender Patients are randomized to one of two treatment arms
Arm I Patients with stage I or II disease undergo radiotherapy once daily for 6-7 weeks Patients with stage III or IV disease undergo radiotherapy once daily for 35 weeks and then twice daily 6 hours apart for 25 weeks for a total of 6 weeks
Arm II Patients undergo radiotherapy as in arm I Beginning 7-10 days before radiotherapy patients receive epoetin alfa subcutaneously once weekly until the end of radiotherapy
Patients with stage IIIIV disease may receive concurrent cisplatin IV over 1-2 hours on days 1 and 22 of radiotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 372 patients 186 per arm will be accrued for this study within 35 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 |
|---|---|---|---|
| CDR0000067599 | None | None | None |