Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053768
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2003-02-05
Brief Title:
Combination Chemotherapy Followed By Radiation Therapy in Treating Patients With Aggressive Non-Hodgkins Lymphoma
Sponsor:
German High-Grade Non-Hodgkins Lymphoma Study Group
Organization:
Universität des Saarlandes
Study Overview
Official Title:
Randomised Trial Comparing Chemotherapy Mit CHOEP Cyclophosphamid Doxorubicin Vincristin Etoposid Und Prednison In 21-Day Intervals In Standard And Escalated Doses In Patients Aged 18-60 Years Of Age With Aggresive Non-Hodgkin-Lymphomas Favourable Prognoses
Status:
COMPLETED
Status Verified Date:
2021-05
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 Combining more than one drug and giving the drugs in different ways may kill more cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells It is not yet known which combination chemotherapy regimen followed by radiation therapy is more effective in treating aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying two combination chemotherapy regimens followed by radiation therapy to compare how well they work in treating patients with aggressive non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare the efficacy of standard-dose vs high-dose cyclophosphamide doxorubicin vincristine etoposide and prednisone followed by radiotherapy in terms of time to treatment failure in patients with aggressive non-Hodgkins lymphoma
Compare the acute and long-term toxic effects of these regimens in these patients
Compare the complete response rate survival and tumor control and disease-free survival in patients treated with these regimens
Analyze the time to relapse after radiotherapy in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to LDH levels no greater than upper limit of normal ULN vs greater than ULN initial bulky disease yes vs no stage I or II vs II or IV ECOG performance status 0 or 1 vs 2 or 3 and participating center Patients are randomized to 1 of 2 treatment arms as follows
Arm I Standard dose Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 etoposide IV on days 1-3 and oral prednisone on days 1-5 CHOEP in standard doses
Arm II Escalated dose Patients receive high-dose CHOEP as in arm I Patients also receive filgrastim G-CSF subcutaneously on days 6-12
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of CHOEP chemotherapy patients with initial bulky disease or extranodal involvement undergo radiotherapy 5 days a week for 4 weeks
Patients who undergo radiotherapy are followed at 2 months after radiotherapy All patients including those who undergo radiotherapy are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 389 patients were accrued for this study
Compare the efficacy of standard-dose vs high-dose cyclophosphamide doxorubicin vincristine etoposide and prednisone followed by radiotherapy in terms of time to treatment failure in patients with aggressive non-Hodgkins lymphoma
Compare the acute and long-term toxic effects of these regimens in these patients
Compare the complete response rate survival and tumor control and disease-free survival in patients treated with these regimens
Analyze the time to relapse after radiotherapy in these patients
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to LDH levels no greater than upper limit of normal ULN vs greater than ULN initial bulky disease yes vs no stage I or II vs II or IV ECOG performance status 0 or 1 vs 2 or 3 and participating center Patients are randomized to 1 of 2 treatment arms as follows
Arm I Standard dose Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 etoposide IV on days 1-3 and oral prednisone on days 1-5 CHOEP in standard doses
Arm II Escalated dose Patients receive high-dose CHOEP as in arm I Patients also receive filgrastim G-CSF subcutaneously on days 6-12
In both arms treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of CHOEP chemotherapy patients with initial bulky disease or extranodal involvement undergo radiotherapy 5 days a week for 4 weeks
Patients who undergo radiotherapy are followed at 2 months after radiotherapy All patients including those who undergo radiotherapy are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 389 patients were accrued for this study
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 |
|---|---|---|---|
| DSHNHL-1999-2 | None | None | None |
| EU-20242 | None | None | None |