Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005867
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-06-02
Brief Title:
Combination Chemotherapy in Treating Patients With Aggressive Non-Hodgkins Lymphoma
Sponsor:
Lymphoma Trials Office
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial Comparing CHOP ot PMitCEBO in Good Risk Patients With Histologically Aggresive Non Hodgkins Lymphoma
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die It is not yet known which regimen of combination chemotherapy is most effective for non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two regimens of combination chemotherapy and comparing how well they work in treating patients with aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the overall survival failure free survival disease specific survival relapse free survival and response rate in patients with aggressive non-Hodgkins lymphoma treated with mitoxantrone cyclophosphamide etoposide vincristine bleomycin and prednisolone PMitCEBO versus cyclophosphamide doxorubicin vincristine and prednisolone CHOP
Compare the early and late toxicities of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 and vincristine and bleomycin IV on day 8 Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment
Arm II Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisolone on days 1-5 Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks then every 3 months for 1 year every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 310 patients 155 per arm will be accrued for this study over 5 years
Compare the overall survival failure free survival disease specific survival relapse free survival and response rate in patients with aggressive non-Hodgkins lymphoma treated with mitoxantrone cyclophosphamide etoposide vincristine bleomycin and prednisolone PMitCEBO versus cyclophosphamide doxorubicin vincristine and prednisolone CHOP
Compare the early and late toxicities of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms
Arm I Patients receive mitoxantrone IV cyclophosphamide IV and etoposide IV on day 1 and vincristine and bleomycin IV on day 8 Treatment continues every 14 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral prednisolone daily on courses 1 and 2 and every other day beginning on course 3 and continuing until the end of treatment
Arm II Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral prednisolone on days 1-5 Treatment continues every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks then every 3 months for 1 year every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 310 patients 155 per arm will be accrued for this study over 5 years
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 |
|---|---|---|---|
| EU-99052 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067900 | REGISTRY | None | None |