Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028938
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2002-01-04
Brief Title:
Chemotherapy and Radiation Therapy With or Without Epoetin Alfa in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Randomized Trial Evaluating the Effect of Epoetin Alfa Procrit on Local Control in Patients Undergoing Concurrent Chemotherapy and Radiation Therapy for Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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 Radiation therapy uses high-energy x-rays to damage tumor cells Epoetin alfa may stimulate red blood cell production and prevent or treat anemia in patients who are undergoing radiation therapy and chemotherapy It is not yet known if chemotherapy combined with radiation therapy is more effective with or without epoetin alfa in treating non-small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer
PURPOSE Randomized phase III trial to determine the effectiveness of chemotherapy combined with radiation therapy with or without epoetin alfa in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy
Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa
Compare tumor response rate and overall survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life in patients treated with these regimens
Compare the number of transfusions in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Karnofsky performance status 90-100 vs 60-80 weight loss no more than 5 vs 6-10 and baseline hemoglobin women 110-124 gdL and men 110-134 gdL vs women 125-150 gdL and men 135-150 gdL Patients are randomized to 1 of 2 treatment arms
Arm I Beginning 7-10 days before the start of chemoradiotherapy patients receive epoetin alfa subcutaneously once weekly for 8 weeks Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel carboplatin and radiotherapy as in arm I Quality of life is assessed at baseline at completion of chemoradiotherapy every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 202-232 patients 101-116 per treatment arm will be accrued for this study within 17-2 years
Determine the efficacy of epoetin alfa in maintaining hemoglobin levels in patients with stage IIIA or IIIB non-small cell lung cancer when treated with chemoradiotherapy
Compare the time to local and systemic progression in patients receiving chemoradiotherapy with or without epoetin alfa
Compare tumor response rate and overall survival in patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare quality of life in patients treated with these regimens
Compare the number of transfusions in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to Karnofsky performance status 90-100 vs 60-80 weight loss no more than 5 vs 6-10 and baseline hemoglobin women 110-124 gdL and men 110-134 gdL vs women 125-150 gdL and men 135-150 gdL Patients are randomized to 1 of 2 treatment arms
Arm I Beginning 7-10 days before the start of chemoradiotherapy patients receive epoetin alfa subcutaneously once weekly for 8 weeks Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 7 weeks Patients undergo radiotherapy 5 days a week for 7 weeks for a total of 33 treatments Treatment continues in the absence of disease progression or unacceptable toxicity
Arm II Patients receive paclitaxel carboplatin and radiotherapy as in arm I Quality of life is assessed at baseline at completion of chemoradiotherapy every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 202-232 patients 101-116 per treatment arm will be accrued for this study within 17-2 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 |
|---|---|---|---|
| NCI-P01-0200 | None | None | None |
| CCCWFU-62299 | None | None | None |
| CCCWFU-BG01-193 | None | None | None |