Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049595
Status:
COMPLETED
Last Update Posted:
2023-11-09
First Post:
2002-11-12
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV 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:
BEACOPP 4 Cycles Escalated 4 Cycles Baseline Versus ABVD 8 Cycles In Stage III IV Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-11
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 cancer cells It is not yet known which combination chemotherapy regimen is more effective in treating stage III or stage IV Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkins lymphoma
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III or stage IV Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Compare event-free survival of patients with stage III or IV Hodgkins lymphoma treated with bleomycin etoposide doxorubicin cyclophosphamide vincristine procarbazine and prednisone vs doxorubicin bleomycin vinblastine and dacarbazine
Compare complete response disease-free survival and overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare occurrence of second malignancies in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to International Prognostic Score 3 vs 4 or more and participating center Patients are randomized to 1 of 2 treatment arms
Arm I BEACOPP Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1 etoposide IV over 30 minutes on days 1-3 oral procarbazine on days 1-7 oral prednisone on days 1-14 and vincristine IV and bleomycin IV or intramuscularly IM on day 8 Patients may receive dexamethasone in place of prednisone Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only Treatment repeats every 22 days for 8 courses 4 courses escalated dose followed by 4 courses baseline dose in the absence of disease progression or unacceptable toxicity
Arm II ABVD Patients receive doxorubicin IV over 5 minutes bleomycin IV or IM vinblastine IV and dacarbazine IV over 5-10 minutes on days 1 and 15 Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of therapy and then annually for 10 years
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 550 patients 225 per treatment arm will be accrued for this study within 55 years
Compare event-free survival of patients with stage III or IV Hodgkins lymphoma treated with bleomycin etoposide doxorubicin cyclophosphamide vincristine procarbazine and prednisone vs doxorubicin bleomycin vinblastine and dacarbazine
Compare complete response disease-free survival and overall survival of patients treated with these regimens
Compare quality of life of patients treated with these regimens
Compare occurrence of second malignancies in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to International Prognostic Score 3 vs 4 or more and participating center Patients are randomized to 1 of 2 treatment arms
Arm I BEACOPP Patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV on day 1 etoposide IV over 30 minutes on days 1-3 oral procarbazine on days 1-7 oral prednisone on days 1-14 and vincristine IV and bleomycin IV or intramuscularly IM on day 8 Patients may receive dexamethasone in place of prednisone Patients also receive filgrastim G-CSF subcutaneously SC beginning on day 9 and continuing until blood counts recover or pegfilgrastim SC on day 9 only Treatment repeats every 22 days for 8 courses 4 courses escalated dose followed by 4 courses baseline dose in the absence of disease progression or unacceptable toxicity
Arm II ABVD Patients receive doxorubicin IV over 5 minutes bleomycin IV or IM vinblastine IV and dacarbazine IV over 5-10 minutes on days 1 and 15 Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline at the end of therapy and then annually for 10 years
Patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 550 patients 225 per treatment arm will be accrued for this study within 55 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 |
|---|---|---|---|
| 2004-001558-10 | EUDRACT_NUMBER | ALLG | None |
| EORTC-20012 | OTHER | None | None |
| GELA-EORTC-20012 | OTHER | None | None |
| BNLI-EORTC-20012 | OTHER | None | None |
| GELCAB-EORTC-20012 | OTHER | None | None |
| NORDICLG-EORTC-20012 | OTHER | None | None |
| CAN-NCIC-EORTC-20012 | OTHER | None | None |
| ALLG-HD04 | OTHER | None | None |