drugset / Trial / NCT00049595

Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Stage III or Stage IV Hodgkin's Lymphoma

Phase 3 Completed 552 enrolled European Organisation for Research and Treatment of Cancer - EORTC Australasian Leukaemia and Lymphoma Group · collab Grup per l'Estudi dels Limfomes de Catalunya i Balears · collab Lymphoma Study Association · collab Lymphoma Trials Office · collab NCIC Clinical Trials Group · collab Nordic Lymphoma Group · collab

RandomizedParallel-groupOpen-labelTreatment

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 Hodgkin's 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 Hodgkin's lymphoma.

Timeline

Start: 2002-08
Primary completion: 2010-01
Completion: —

Outcome

Missed primary endpoint

paper At 4 years, EFS was 63.7% for ABVD8 versus 69.3% for BEACOPP4+4 (hazard ratio [HR], 0.86; 95% CI, 0.64 to 1.15; P = .312); PMID 27114593 ↗

paper Because BEACOPP4+4 did not demonstrate a favorable effectiveness or toxicity ratio compared with ABVD8 PMID 27114593 ↗

Publications

Carde P, Karrasch M, Fortpied C, Brice P, Khaled H, Casasnovas O, Caillot D, Gaillard I, Bologna S, Ferme C, Lugtenburg PJ, Morschhauser F, Aurer I, Coiffier B, Meyer R, Seftel M, Wolf M, Glimelius B, Sureda A, Mounier N. Eight Cycles of ABVD Versus Four Cycles of BEACOPPescalated Plus Four Cycles of BEACOPPbaseline in Stage III to IV, International Prognostic Score >/= 3, High-Risk Hodgkin Lymphoma: First Results of the Phase III EORTC 20012 Intergroup Trial. J Clin Oncol. 2016 Jun 10;34(17):2028-36. doi: 10.1200/JCO.2015.64.5648. Epub 2016 Apr 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bleomycin	Unknown	—	Intravenous
Subject	Cyclophosphamide	Other / unclassified	—	Intravenous
Comparator	Dacarbazine	Small molecule	—	Intravenous
Subject	Doxorubicin	Other / unclassified	—	Intravenous
Subject	Etoposide	Small molecule	—	Intravenous
Subject	Prednisone	Other / unclassified	—	Oral
Comparator	Vinblastine	Small molecule	—	Intravenous
Subject	Vincristine	Small molecule	—	Intravenous
Subject	procarbazine	Small molecule	—	Oral
Background	Pegfilgrastim	Protein / enzyme biologic	—	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	—	Subcutaneous