Status: Closed
Activation Date: 2003MAY13
Closing Date: 2010JAN08
Phase: III
Description: BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma
Eligibility: Patients with histologically documented Hodgkin's lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma). Patients must be clinical stage III or IV and have at least one bi-dimensionally measurable target lesion. Patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.
Objective: The primary end point is Event-Free-Survival (EFS), also called Time to Treatment Failure or Freedom From Treatment Failure (FFTF). For this end-point, an "event" is defined as early discontinuation of protocol treatment, absence of CR after 8 cycles, relapse, progression or death. The secondary endpoints are: complete response (CR), disease free survival (DFS) in CR patients, overall survival (OS), quality of life (QoL), occurrence of second malignancies and cost effectiveness.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects on the patient and their Hodgkins disease between treatment with BEACOPP compared to standard treatment with ABVD. This research is being done because currently it is not known which of these two treatments is better. Treatment with BEACOPP has been used in previous studies and seems promising, however it is not clear if it can offer better results than standard treatment with ABVD.
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| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| HEMATOLOGIC | HD8 | 43 | 12 | 29 | 29 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| HEMATOLOGIC | HD8 | 43 | 0 | 0 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| HEMATOLOGIC | HD8 | 43 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |