Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017004
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2001-06-06
Brief Title:
Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Phase III Trial to Evaluate the Efficacy of Maintaining Hemoglobin Levels Above 120 gl With Erythropoietin Versus Above 100 gl Without Erythropoietin in Anemic Patients Receiving Concurrent Radiation and Cisplatin for Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2017-08
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:
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 to treat anemia in patients who have received chemotherapy andor radiation therapy for cervical cancer Randomized phase III trial to study the effectiveness of epoetin alfa in treating anemia in patients who have cervical cancer
Detailed Description:
OBJECTIVES
Assess the efficacy of raising and maintaining hemoglobin Hgb levels above 120 gdL with epoetin alfa vs maintaining Hgb levels above 100 gdL without epoetin alfa on progression-free survival overall survival and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin Compare the quality of life of patients treated with these regimens
OUTLINE
This is a randomized study Patients are stratified according to stage IIB vs IIIB vs IVA method of brachytherapy low-dose vs high-dose and surgical staging of para-aortic nodes yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy followed by 3-5 days of parametrial boost radiotherapy Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1 8 15 22 29 and once during the week of parametrial boost radiotherapy
Arm II Patients undergo radiotherapy and chemotherapy as in arm I Additionally patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy Quality of life is assessed at baseline during weeks 3 and 6 within 1 week of last brachytherapy and every 3 months for 2 years Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients will be accrued for this study within 35 years
Assess the efficacy of raising and maintaining hemoglobin Hgb levels above 120 gdL with epoetin alfa vs maintaining Hgb levels above 100 gdL without epoetin alfa on progression-free survival overall survival and local control in anemic patients with cervical cancer receiving concurrent radiotherapy and cisplatin Compare the quality of life of patients treated with these regimens
OUTLINE
This is a randomized study Patients are stratified according to stage IIB vs IIIB vs IVA method of brachytherapy low-dose vs high-dose and surgical staging of para-aortic nodes yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo radiotherapy comprising pelvic external beam radiotherapy daily five days a week for 5 weeks followed by either 1 or 2 implants of low-dose rate intracavitary brachytherapy or 5 fractions of high-dose rate intracavitary brachytherapy followed by 3-5 days of parametrial boost radiotherapy Patients receive cisplatin IV concurrently with pelvic external beam radiotherapy on days 1 8 15 22 29 and once during the week of parametrial boost radiotherapy
Arm II Patients undergo radiotherapy and chemotherapy as in arm I Additionally patients receive epoetin alfa subcutaneously once weekly concurrently with radiotherapy and chemotherapy Quality of life is assessed at baseline during weeks 3 and 6 within 1 week of last brachytherapy and every 3 months for 2 years Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 460 patients 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 |
|---|---|---|---|
| NCI-2012-02384 | REGISTRY | None | None |
| CAN-NCIC-CX4 | None | None | None |
| CDR0000068641 | None | None | None |
| GOG-0191 | OTHER | None | None |
| GOG-0191 | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |