Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039351
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2002-06-06
Brief Title:
Combination Chemotherapy in Treating Older Patients With 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:
Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkins Lymphoma In The Frail Elderly Progressive And Cautious Treatment Strategy In Poor Status Patients A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the complete remission CR rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkins lymphoma treated with cyclophosphamide vincristine and prednisone
Determine the time to progression and overall survival of patients treated with this regimen
Determine the severe toxicity rate of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients with stage I or II non-Hodgkins lymphoma NHL no baseline lactate dehydrogenase LDH elevation baseline WHO performance status 0-1 and longest tumor diameter of less than 5 cm who achieve partial response PR or complete response CR receive 1 additional course of chemotherapy Patients then undergo involved-field radiotherapy once daily 5 days a week for 35-4 weeks
Patients with stage I or II NHL a baseline LDH elevation andor baseline WHO performance status 2-4 andor longest tumor diameter of at least 5 cm who achieve PR or CR receive 3 additional courses of chemotherapy Patients then undergo involved-field radiotherapy once daily 5 days a week for 35-4 weeks
Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy Patients then undergo consolidative radiotherapy once daily 5 days a week for 25-3 weeks
Quality of life is assessed at baseline after the third chemotherapy course at the end of chemotherapy every 6 months for 3 years and then annually thereafter
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-56 patients will be accrued for this study within 12-18 months
Determine the complete remission CR rate and duration of CR in frail elderly patients with diffuse large B-cell or peripheral T-cell non-Hodgkins lymphoma treated with cyclophosphamide vincristine and prednisone
Determine the time to progression and overall survival of patients treated with this regimen
Determine the severe toxicity rate of this regimen in these patients
Assess the quality of life of patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cyclophosphamide IV and vincristine IV on day 1 and oral prednisone on days 1-5 Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients with stage I or II non-Hodgkins lymphoma NHL no baseline lactate dehydrogenase LDH elevation baseline WHO performance status 0-1 and longest tumor diameter of less than 5 cm who achieve partial response PR or complete response CR receive 1 additional course of chemotherapy Patients then undergo involved-field radiotherapy once daily 5 days a week for 35-4 weeks
Patients with stage I or II NHL a baseline LDH elevation andor baseline WHO performance status 2-4 andor longest tumor diameter of at least 5 cm who achieve PR or CR receive 3 additional courses of chemotherapy Patients then undergo involved-field radiotherapy once daily 5 days a week for 35-4 weeks
Patients with stage III or IV NHL who achieve CR or PR receive 3 additional courses of chemotherapy Patients then undergo consolidative radiotherapy once daily 5 days a week for 25-3 weeks
Quality of life is assessed at baseline after the third chemotherapy course at the end of chemotherapy every 6 months for 3 years and then annually thereafter
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 29-56 patients will be accrued for this study within 12-18 months
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-20992 | None | None | None |