Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079261
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2004-03-08
Brief Title:
Cyclophosphamide Doxorubicin Vincristine and Prednisone With or Without Gemcitabine in Treating Patients With Previously Untreated Aggressive Non-Hodgkins Lymphoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Gem-CHOP A Randomized Phase II Study of Gemcitabine Combined With CHOP in Untreated Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-09
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 such as cyclophosphamide doxorubicin vincristine prednisone and gemcitabine work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more cancer cells
PURPOSE This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II stage III or stage IV non-Hodgkins lymphoma
PURPOSE This randomized phase II trial is studying giving combination chemotherapy together with gemcitabine to see how well it works compared to giving combination chemotherapy alone in treating patients with previously untreated aggressive stage II stage III or stage IV non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare the complete response rate confirmed or unconfirmed in patients with previously untreated aggressive non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone with vs without gemcitabine
Secondary
Compare the safety profile of these regimens in these patients
Compare the feasibility of these regimens defined as the proportion of courses given as scheduled in these patients
Compare freedom from treatment failure in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center International Prognostic Index score 0-2 vs 3-5 and histology B cell vs T cell Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral or IV prednisone on days 1-5
Arm II Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
In both arms treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy for a total of 8 courses
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 76-82 patients 38-41 per treatment arm will be accrued for this study within 2 years
Primary
Compare the complete response rate confirmed or unconfirmed in patients with previously untreated aggressive non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone with vs without gemcitabine
Secondary
Compare the safety profile of these regimens in these patients
Compare the feasibility of these regimens defined as the proportion of courses given as scheduled in these patients
Compare freedom from treatment failure in patients treated with these regimens
OUTLINE This is an open-label randomized multicenter study Patients are stratified according to participating center International Prognostic Index score 0-2 vs 3-5 and histology B cell vs T cell Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive CHOP chemotherapy comprising cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 and oral or IV prednisone on days 1-5
Arm II Patients receive CHOP chemotherapy as in arm I and gemcitabine IV over 30 minutes on days 1 and 8
In both arms treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity or progressive disease Patients achieving partial response or complete or unconfirmed complete response receive an additional 5 courses of therapy for a total of 8 courses
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 76-82 patients 38-41 per treatment arm will be accrued for this study within 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 |
|---|---|---|---|
| EORTC-20021 | None | None | None |