Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060385
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2003-05-06
Brief Title:
Combination Chemotherapy With or Without Etoposide 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 Lymphomas NHL In The Elderly Influence Of Prolonged Oral Etoposide Added To CHOP Combination Chemotherapy In Patients With Good Physiological Status An EORTC Randomized Phase II-III Trial Including Geriatric Assessment And Quality Of Life
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 cancer cells It is not yet known which combination chemotherapy regimen is more effective in treating non-Hodgkins lymphoma
PURPOSE Randomized phase IIIII trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkins lymphoma that has not been previously treated
PURPOSE Randomized phase IIIII trial to compare the effectiveness of combination chemotherapy with or without etoposide in treating older patients who have non-Hodgkins lymphoma that has not been previously treated
Detailed Description:
OBJECTIVES
Compare the complete response rates in older patients with diffuse large B-cell or peripheral T-cell non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with vs without etoposide
Compare the overall survival of patients treated with these regimens
Compare the time to treatment failure in patients treated with these regimens
Compare the freedom from progression in patients treated with these regimens
Determine the toxicity of CHOP plus etoposide in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to cellular type B-cell vs T-cell initial stage of disease I and II vs III and IV WHO performance status 0-1 vs 2 and lactic dehydrogenase level LDH normal vs abnormal Patients are randomized to 1 of 2 treatment arms
Arm I CHOP chemotherapy Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Patients then undergo disease evaluation
Patients with disease progression or no change in disease are removed from study Patients with responsive stage I or II disease receive 1 additional course if they demonstrate all 3 of the following conditions at baseline no LDH elevation WHO performance status of 0-1 and greatest single diameter of any tumor site less than 5 cm Patients with responsive stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the following conditions at baseline LDH elevation WHO performance status 2 andor greatest single diameter of any tumor site at least 5 cm Patients with responsive stage III or IV disease receive 3 additional courses
After the completion of chemotherapy patients with responsive stage I or II disease undergo involved field radiotherapy once daily 5 days a week for 35-4 weeks Patients with initial bulky stage III or IV disease may also undergo radiotherapy
Arm II CHOP chemotherapy and etoposide Patients receive CHOP chemotherapy as in arm I plus oral etoposide 2 or 3 times daily on days 1-10 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Patients receive additional courses as in arm I
After the completion of chemotherapy patients with responsive stage I or II disease or initial bulky stage III or IV disease undergo radiotherapy as in arm I
Quality of life is assessed at baseline after course 3 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 686 patients 126 for phase II and 560 for phase III will be accrued for this study within 5 years
Compare the complete response rates in older patients with diffuse large B-cell or peripheral T-cell non-Hodgkins lymphoma treated with cyclophosphamide doxorubicin vincristine and prednisone CHOP with vs without etoposide
Compare the overall survival of patients treated with these regimens
Compare the time to treatment failure in patients treated with these regimens
Compare the freedom from progression in patients treated with these regimens
Determine the toxicity of CHOP plus etoposide in these patients
Compare the quality of life of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to cellular type B-cell vs T-cell initial stage of disease I and II vs III and IV WHO performance status 0-1 vs 2 and lactic dehydrogenase level LDH normal vs abnormal Patients are randomized to 1 of 2 treatment arms
Arm I CHOP chemotherapy Patients receive cyclophosphamide IV doxorubicin IV and vincristine IV on day 1 Patients also receive oral prednisone on days 1-5 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Patients then undergo disease evaluation
Patients with disease progression or no change in disease are removed from study Patients with responsive stage I or II disease receive 1 additional course if they demonstrate all 3 of the following conditions at baseline no LDH elevation WHO performance status of 0-1 and greatest single diameter of any tumor site less than 5 cm Patients with responsive stage I or II disease receive 3 additional courses if they demonstrate 1 or more of the following conditions at baseline LDH elevation WHO performance status 2 andor greatest single diameter of any tumor site at least 5 cm Patients with responsive stage III or IV disease receive 3 additional courses
After the completion of chemotherapy patients with responsive stage I or II disease undergo involved field radiotherapy once daily 5 days a week for 35-4 weeks Patients with initial bulky stage III or IV disease may also undergo radiotherapy
Arm II CHOP chemotherapy and etoposide Patients receive CHOP chemotherapy as in arm I plus oral etoposide 2 or 3 times daily on days 1-10 Treatment repeats every 21 days for 3 courses in the absence of unacceptable toxicity Patients receive additional courses as in arm I
After the completion of chemotherapy patients with responsive stage I or II disease or initial bulky stage III or IV disease undergo radiotherapy as in arm I
Quality of life is assessed at baseline after course 3 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 686 patients 126 for phase II and 560 for phase III will be accrued for this study within 5 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-20991 | None | None | None |