Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046969
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2002-10-03
Brief Title:
Epoetin Beta in Treating Anemia in Patients With Cervical Cancer
Sponsor:
AGO Study Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Management Of Anemia Under RadioChemotherapy MARCH An Open Randomized Multicenter Study Of The Effect Of NeoRecormon On Treatment Outcome In Patients With Advanced Cervical Cancer Stage IIB -IVA Treated With Primary Simultaneous Radiochemotherapy Radiotherapy Plus Cisplatin
Status:
COMPLETED
Status Verified Date:
2007-03
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 Epoetin beta may stimulate red blood cell production to prevent or control anemia in patients treated with chemotherapy and radiation therapy
PURPOSE Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB stage III or stage IVA cervical cancer
PURPOSE Randomized phase IV trial to determine the effectiveness of epoetin beta in treating anemia in patients who are receiving cisplatin and radiation therapy for stage IIB stage III or stage IVA cervical cancer
Detailed Description:
OBJECTIVES
Compare the effectiveness of epoetin beta vs standard care for anemia management in terms of increased hemoglobin levels and the correlation with reduced relapsetreatment failure rate in patients with stage IIB III or IVA cervical cancer treated with cisplatin and radiotherapy
Compare the safety of these regimens in these patients
Compare the relapse-free and overall survival of patients treated with these regimens
Compare the frequency and localization of relapses and metastases in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the type frequency and degree of adverse events in patients treated with these regimens
Compare the overall response rate in patients treated with these regimens
OUTLINE This is a randomized open-label parallel-group multicenter study Patients are stratified according to country disease stage and brachytherapy technique Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Patients also undergo high-dose rate low-dose rate or boost brachytherapy Patients receive cisplatin IV beginning on day 1 of radiotherapy and continuing weekly for 6 weeks Patients also receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before radiotherapy and continuing for 8 weeks
Arm II Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm I
Quality of life is assessed at baseline after the last treatment and at 3 months
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 80-450 patients will be accrued for this study within 4-225 months
Compare the effectiveness of epoetin beta vs standard care for anemia management in terms of increased hemoglobin levels and the correlation with reduced relapsetreatment failure rate in patients with stage IIB III or IVA cervical cancer treated with cisplatin and radiotherapy
Compare the safety of these regimens in these patients
Compare the relapse-free and overall survival of patients treated with these regimens
Compare the frequency and localization of relapses and metastases in patients treated with these regimens
Compare the quality of life of patients treated with these regimens
Compare the type frequency and degree of adverse events in patients treated with these regimens
Compare the overall response rate in patients treated with these regimens
OUTLINE This is a randomized open-label parallel-group multicenter study Patients are stratified according to country disease stage and brachytherapy technique Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy 5 days a week for 6 weeks Patients also undergo high-dose rate low-dose rate or boost brachytherapy Patients receive cisplatin IV beginning on day 1 of radiotherapy and continuing weekly for 6 weeks Patients also receive epoetin beta subcutaneously 3 times a week beginning 2 weeks before radiotherapy and continuing for 8 weeks
Arm II Patients undergo radiotherapy and brachytherapy and receive cisplatin as in arm I
Quality of life is assessed at baseline after the last treatment and at 3 months
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 80-450 patients will be accrued for this study within 4-225 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ROCHE-RO2053859 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000257189 | REGISTRY | None | None |
| EU-20217 | None | None | None |
| ROCHE-MO16375 | None | None | None |